FDA Registration
Active
🇺🇸 United States
O&M Halyard, Inc.
Reg #: 3014421917
·
FEI: 3014421917
·
Expires 2026
Products
124
Proprietary Names
240
Establishment Types
5
Classifications
124
Registration Details
- Registration Name
- O&M Halyard, Inc.
- Registration Number
- 3014421917
- FEI Number
- 3014421917
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1220 Old Alpharetta Rd Ste 320
- City
- Alpharetta
- State
- GA
- ZIP
- 30005
- Country
- US
Regulatory Submissions
- 510(k) Number
- K171873
Owner / Operator
- Firm Name
- O&M Halyard, Inc.
- Operator Number
- 10057479
- Address
- 1220 Old Alpharetta Rd, Suite 320
- City
- Alpharetta
- State
- GA
- Postal Code
- 30005
- Country
- US
- Correspondent
- Angela Bunn
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2025-07-09 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2025-07-09 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2024-09-26 |
| Wheelchair, Mechanical | IOR | Class 1 | Physical Medicine | No | 2025-01-14 |
| Crutch | IPR | Class 1 | Physical Medicine | No | 2025-01-14 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2025-06-27 |
| Saline, Vascular Access Flush | NGT | Class 2 | General Hospital | No | 2021-08-16 |
| Component, External, Limb, Ankle/Foot | ISH | Class 1 | Physical Medicine | No | 2023-06-19 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2025-01-14 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2018-06-28 |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | Class 2 | Gastroenterology, Urology | No | 2025-07-11 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2025-07-11 |
| Fentanyl And Other Opioid Protection Glove | QDO | Class 1 | General Hospital | No | 2021-01-14 |
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2022-03-09 |
| Stirrup, External Brace Component | ITC | Class 1 | Physical Medicine | No | 2023-07-14 |
| Vinyl Patient Examination Glove | LYZ | Class 1 | General Hospital | No | 2025-01-14 |
| Gown, Isolation, Surgical | FYC | Class 2 | General, Plastic Surgery | No | 2024-05-17 |
| Splint, Hand, And Components | ILH | Class 1 | Physical Medicine | No | 2018-05-02 |
| Clamp, Umbilical | HFW | Class 2 | Obstetrics/Gynecology | No | 2025-01-13 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2025-01-14 |
| Cover, Limb | IPM | Class 1 | Physical Medicine | No | 2024-07-15 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2025-01-14 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2025-01-14 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2018-05-31 |
| Stretcher, Patient Restraint | NZD | Class 1 | General Hospital | No | 2018-05-02 |
| Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs | OPJ | Class 1 | General Hospital | No | 2025-12-11 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2025-01-13 |
| Connector, Catheter | GCD | Class 1 | General, Plastic Surgery | No | 2025-07-09 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2025-01-13 |
| Device, Intravascular Catheter Securement | KMK | Class 1 | General Hospital | No | 2025-07-09 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2018-05-02 |
| Chamber, Patient Isolation | LGM | Class 2 | General Hospital | No | 2023-02-20 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2025-07-09 |
| Coverslips, Microscope Slide | KES | Class 1 | Pathology | No | 2025-07-09 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2023-06-19 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2025-03-07 |
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2025-01-14 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2018-05-02 |
| Tissue Adhesive For The Topical Approximation Of Skin | MPN | Class 2 | General, Plastic Surgery | No | 2025-01-14 |
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2025-01-14 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2025-01-14 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2025-07-09 |
| Tips And Pads, Cane, Crutch And Walker | INP | Class 1 | Physical Medicine | No | 2025-01-14 |
| Solvent, Adhesive Tape | KOX | Class 1 | General, Plastic Surgery | No | 2025-01-14 |
| Pill Crusher/Cutter | OHY | Class 1 | General Hospital | No | 2025-07-09 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2025-01-13 |
| Catheter, Straight | EZD | Class 2 | Gastroenterology, Urology | No | 2025-07-09 |
| Band Or Belt, Pelvic Support | ISR | Class 1 | Physical Medicine | No | 2024-02-23 |
| Speculum, Vaginal, Nonmetal | HIB | Class 2 | Obstetrics/Gynecology | No | 2025-01-14 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2025-01-14 |
| Tourniquet, Nonpneumatic | GAX | Class 1 | General, Plastic Surgery | No | 2025-01-13 |
| Monitor, Bed Patient | KMI | Class 1 | General Hospital | No | 2025-07-09 |
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | FCM | Class 2 | Gastroenterology, Urology | No | 2025-01-14 |
| Walker, Mechanical | ITJ | Class 1 | Physical Medicine | No | 2025-01-14 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2025-07-09 |
| Trap, Sterile Specimen | BYZ | Class 2 | General Hospital | No | 2025-07-09 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2022-08-05 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2025-01-13 |
| System, Thermal Regulating | DWJ | Class 2 | Cardiovascular | No | 2018-05-02 |
| Cap, Surgical | FYF | Class 1 | General, Plastic Surgery | No | 2018-05-02 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2025-01-13 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2025-07-11 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2018-05-02 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2025-03-26 |
| Attachment, Commode, Wheelchair | INB | Class 1 | Physical Medicine | No | 2025-07-09 |
| Appliance, Colostomy, Disposable | EZS | Class 1 | Gastroenterology, Urology | No | 2024-09-24 |
| Pediatric/Child Facemask | OXZ | Class 2 | General, Plastic Surgery | No | 2018-05-02 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2018-05-02 |
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2025-01-14 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2025-07-09 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2025-01-14 |
| Warmer, Irrigation Solution | LHC | Class 1 | Physical Medicine | No | 2021-11-30 |
| Indicator, Biological Sterilization Process | FRC | Class 2 | General Hospital | No | 2023-04-05 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2025-01-13 |
| Surgical Table Cushion | LWG | Class 1 | General, Plastic Surgery | No | 2018-05-02 |
| Catheter, Infusion | JCY | Class 1 | General, Plastic Surgery | No | 2023-06-19 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2021-08-06 |
| Drape, Adhesive, Aerosol | KGT | Class 1 | General, Plastic Surgery | No | 2022-11-02 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2025-07-09 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2018-04-27 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2025-03-26 |
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2023-04-05 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2025-01-13 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 2018-05-02 |
| Suit, Surgical | FXO | Class 1 | General, Plastic Surgery | No | 2018-05-02 |
| Bag, Polymeric Mesh, Pacemaker | DSW | Class 1 | Cardiovascular | No | 2024-02-23 |
| Percutaneous Replacement Gastrostomy Tube Kit | PSH | Class 2 | Gastroenterology, Urology | No | 2025-07-11 |
| Bag, Stomal | GDS | Class 1 | Gastroenterology, Urology | No | 2024-09-24 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2025-01-14 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2025-07-09 |
| Bandage, Liquid, Skin Protectant | NEC | Class 1 | General Hospital | No | 2025-01-14 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2025-01-14 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2025-07-09 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2025-01-13 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2025-01-13 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2018-05-18 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2025-01-10 |
| Cane | IPS | Class 1 | Physical Medicine | No | 2025-01-14 |
| Tube, Feeding | FPD | Class 2 | Gastroenterology, Urology | No | 2025-07-11 |
| Scissors, Umbilical | HDJ | Class 1 | Obstetrics/Gynecology | No | 2025-07-09 |
| Infant Heel Warmer (Chemical Heat Pack) | MPO | Class 1 | Physical Medicine | No | 2025-07-09 |
| Recorder, Paper Chart | DSF | Class 1 | Cardiovascular | No | 2025-07-09 |
| Holder, Ureteral Catheter | EYJ | Class 1 | Gastroenterology, Urology | No | 2025-07-09 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2025-07-09 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2025-07-09 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2025-01-14 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2024-08-21 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2025-07-09 |
| Device, Paste-On For Incontinence, Sterile | EXI | Class 1 | Gastroenterology, Urology | No | 2025-07-09 |
| Infusor, Pressure, For I.V. Bags | KZD | Class 1 | General Hospital | No | 2026-04-29 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2025-01-14 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2018-05-02 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2023-03-01 |
| Aid, Transfer | IKX | Class 1 | Physical Medicine | No | 2025-01-14 |
| Basin, Emesis | FNY | Class 1 | General Hospital | No | 2024-08-21 |
| Shoe And Shoe Cover, Conductive | BWP | Class 1 | General, Plastic Surgery | No | 2018-05-02 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2025-07-09 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2018-04-20 |
| Slides, Microscope | KEW | Class 1 | Pathology | No | 2025-07-09 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2022-02-15 |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | Class 1 | Hematology | No | 2025-07-09 |
| Bed, Ac-Powered Adjustable Hospital | FNL | Class 2 | General Hospital | No | 2025-07-09 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2018-05-02 |
| Counter, Sponge, Surgical | LWH | Class 1 | General Hospital | No | 2025-01-13 |
Proprietary Names
SKYBREEZE* Powder-Free Nitrile Exam Gloves
HALYARD® SEQUENTIAL Sterilization Wrap
HALYARD® ONE-STEP® Sterilization Wrap
HALYARD® QUICK CHECK® Sterilization Wrap
HALYARD® SMART-FOLD® Sterilization Wrap
YK9000 SERIES MANUAL WHEELCHAIR
POLYMER PATIENT EXAM GLOVE
CRUTCH
Sterling Nitrile Powder-Free Exam Gloves
HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops
HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops, WrapAround Visor
HALYARD Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining
HALYARD Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor
HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with Visor
HALYARD Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor
HALYARD Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor
HALYARD Fluidshield * 3 Surgical Mask with SO SOFT* Lining
HALYARD Fluidshield* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops
HALYARD Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, WrapAround Visor
AMSafe(R) Pre-Filled Normal Saline Flush Syringe
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED) AND BLUE COLORED
Personal Stirrup Strap with Slip Ring
AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Blue, WrapAround Visor
HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Blue
PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Gloves
Polyisoprene/Neoprene Hybrid Sterile Surgical Glove
HALYARD* AQUASOFT ZERO* Nitrile Exam Gloves
STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
STERILIZATION WRAP
SURGICAL GOWN
SYNTHETIC VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
Tri-Layer AAMI 3 Isolation Gowns
SPLINT, HAND AND COMPONENTS
Vinyl patient examination glove
Obstetric-gynecologic specialized manual instrument (Clamp, Umbilical)
TUBE, ASPIRATING, FLEXIBLE, CONNECTING
Curaplex® TritonGrip VL Nitrile Exam Gloves
BASICS* Blue Powder-Free Nitrile Exam Gloves
Disposable Powder Free Nitrile Examination Glove, White Color, Tested for Use with Chemotherapy Drugs, Disposable Powder
Cover, Limb
Needle, hypodermic, single lumen
Syringe, piston
SURGICAL DRAPE
Surgical Packs
PATIENT RESTRAINT
Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove
BANDAGE, ELASTIC
POWDER FREE BLUE PATIENT NITRILE EXAMINATION GLOVE
FLEXAPRENE GREEN POWDER-FREE EXAM GLOVES
SYRINGE, IRRIGATING (NON DENTAL)
VINYL PATIENT EXAMINATION GLOVE-POWDER FREE
Latex Powder-Free Sterile Surgical Gloves Tested for use with Chemothera
STERILIZATION WRAP AND ACCESSORIES
Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested With Chemotherapy Drugs
Halyard Purple Nitrile* Powder-Free Exam Gloves
Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fenta
Aero Chrome Select
White Powder-Free Nitrile PPE Exam Gloves
NITRILE POWDER FREE EXAMINATION GLOVES
FLUID CONTROL* Floor Suction Mat
Halyard Surgical N95 Respirator Cup Type Small Size
Halyard Surgical N95 Respirator Cup Type Regular Size
STERILE LUBRICATING JELLY
SMART-FOLD Sterilization Wrap
HALYARD GOWN
Aero Chrome Breathable Performance Surgical Gown
DISPOSABLE HOT / COLD PACK
FLUIDSHIELD* 3 N95 Particulate Filter Respirator and Surgical Mask
LiquiBand Exceed
POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WITH EXTRACTABLE PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAM PER GRAM OF
STETHOSCOPE, MANUAL
Tips and pads, cane, crutch and walker
solvent, adhesive tape
Neoprene Micro Powder-Free Sterile Surgical Gloves
Procedure Mask
Surgical Mask
Gauze / sponge,nonresorbable for external use
POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, STERILE, WITH PROTEIN LABELING CLAIM OF 50 UG PER DM2 OF GLOVE
Fetal Monitor Security Strap with Buttonhole Attachment
HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining
POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED
NON-STERILE DISPOSABLE VAGINAL SPECULUM
Polyisoprene Powder-Free Sterile Surgical Gloves
Dressing, wound, occlusive
HALYARD* Non-Bordered Silicone Foam Dressing
TOURNIQUET, NONPNEUMATIC
Tray, catheterization, sterile urethral, with or without catheter (kit)
Walker, mechanical
POLYMER PATIENT EXAMINATION GLOVE
HALYARD* PUREZERO* Black Nitrile Examination Gloves
Foam Patient Positioning
TRAY, SURGICAL, INSTRUMENT
ASTM Fluid-Rated Procedure Mask
HALYARD* STERLING Nitrile Powder-Free Exam Gloves
NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS
MediChoice
THERMAL REGULATING SYSTEM
Latex Micro Powder-Free Sterile Surgical Gloves
HALYARD* Level 1 Procedure Mask (48388)
HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867)
Regard® Polyisoprene Powder-Free Sterile Surgical Gloves
SURGICAL MASK
FLUIDSHIELD* 2 Expanded Chamber Surgical Mask with SO SOFT* Lining, High Clarity WrapAround Visor
FLUIDSHIELD* 2 Expanded Chamber Surgical Mask with SO SOFT* Lining
SURGICAL CAP
Specimen transport and storage container (Container, Specimen, Non-Sterile)
Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)
EXAMINATION GOWN
Evolution AAMI 4 Surgical Gown
Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs
Impervious Stockinette
HALYARD* Xeroform Dressing
Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gast
HALYARD* Conforming Skin Barrier Ring
HALYARD* Skin Barrier Arc One Half Circle
HALYARD* Skin Barrier Ostomy Powder
Halyard Lavender Nitrile Powder-Free Exam Gloves
Regard® Latex Powder-Free Sterile Surgical Gloves
FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805)
FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802)
FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803)
Scatter Radiation Drape
PEDIATRIC / CHILD FACEMASK
POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE
EYE SHIELD
K160709
CATHETERS, SUCTION, TRACHEOBRONCHIAL
Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114)
Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116)
62115 HALYARD* FLUIDSHIELD* Level 2 Procedure Mask
Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115)
CONTAINER, SPECIMEN, STERILE
Anti-Fog Surgical Mask
FLUID WARMER
Sterilization Monitoring Products
INSTRUMENT, SURGICAL, DISPOSABLE
Halyard Pink Underguard Nitrile Powder-Free Exam Glove
HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
PureZero MARIN Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim
SURGICAL TABLE CUSHION
Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
TUBE-CONTROL PLUS with Hydrogel
HALYARD* Disposable Underpad
Sterilization Pouch Heat Seal-Flat Pack
Tape Strips
HALYARD* SMART-FOLD* Sterilization Wrap (H650)
HALYARD* SMART-FOLD* Sterilization Wrap (H450)
K823078
FLUIDSHIELD* 2 Procedure Mask with SO SOFT* Earloops
FLUIDSHIELD* 2 Fog-Free Procedure Mask with SO SOFT* Earloops, Blue, WrapAround Visor
FLUIDSHIELD* 2 Fog-Free Surgical Mask, Blue with Orange Print
FLUIDSHIELD* 2 Fog-Free Surgical Mask, Blue with Orange Print, WrapAround Visor
FLUIDSHIELD* 2 Procedure Mask with SO SOFT* Earloops, Blue
Fluidshield* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Orange
AERO BLUE SURGICAL GOWN
HALYARD* Gelling Fiber (CMC) Dressing
HALYARD* Alginate Dressing
GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
OPERATING ROOM SHOE COVER
Halyard ONE-STEP Sterilization Wrap
PATIENT EXAMINATION GLOVE, SPECIALTY
Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)
SURGICAL SUIT
PureZero LIMON Nitrile Powder-Free Exam Gloves with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid claim
Telemetry Unit Pouch
HALYARD* Lubricating Deodorant Clear Unscented
SkyBreeze Zero Nitrile Powder-Free Exam Glove
container, liquid medication, graduated
HALYARD* STERLING SG* Nitrile Powder-Free Exam Gloves
ASTM Fluid-Rated Fog-Free Procedure Mask
Bandage, liquid, skin protectant
SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE
HALYARD* Black Powder-Free Nitrile Exam Gloves
Standard Cone Mask
sling, arm
HALYARD* Regional Anesthesia Pain Management Drape
GOWN, DRAPE PACKS
SURGICAL DRAPE HALYARD
Medical adhesive tape and adhesive bandage (Tape and Bandage, Adhesive)
Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves
Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves
SAFESKIN NITRILE EXAM GLOVE
Halyard STERLING* Powder-Free Nitrile Exam Gloves
HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)
PUREZERO Ultra Violet Nitrile Exam Glove
Skybreeze Powder-Free Nitrile Exam Glove
Kit, surgical instrument, disposable
HALYARD PROCEDURE GOWN
ANESTHESIA BREATHING CIRCUIT
Gauze/sponge, internal, x-ray detectable
TRI-LAYER AAMI3 OVER-THE-HEAD ISOLATION GOWN
CANE
Non-Sterile, Powder Free Nitrile Examination Gloves (Blue, Black and White Color)
Fusion Black Powder-Free Nitrile Exam Glove
Nebulizer (direct patient interface)
Safe Secure Sterilization Pouches And Rolls
HALYARD* Absorbent Table Cover
ONE-STEP Sterilization Wrap, QUICK CHECK Sterilization Wrap
CATHETER AND TIP, SUCTION
STERILE POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED
OPERATING ROOM TABLE AND ATTACHMENTS
VALUESELECT* Film-Reinforced Surgical Gown with Towels
VALUESELECT* Standard Surgical Gown with Towels
Probe Cover
AID, TRANSFER
FLUIDSHIELD* 3 Fog-Free Surgical Mask with So Soft* Lining
FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops
FLUIDSHIELD* 3 Fog-Free Procedure Mask with So Soft* Lining
HALYARD* Drawcord Bag, Clear
FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868)
FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798)
SHOE AND SHOE COVER
Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested For Use With Chemotherapy Drugs And And Fenta
Surgical Drape
Equipment Covers
Surgical Drapes and/or accessories
Back Table Covers
Halyard Gown
Surgical Drapes and/or accessories (Stockinette Drapes)
Equipment Drapes
Sterisystem Dry-Base Instrument Tray
ISOLATION SURGICAL GOWN
HALYARD BASICS SURGICAL GOWN
General Surgery Tray
SURGICAL ISOLATION GOWN
Polyisoprene Micro Powder-Free Sterile Surgical Gloves
DERMA PRENE PI OR ISOTOUCH GREEN STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES
Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869)
Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)
Aero Blue Performance Surgical Gowns
Halyard Anti-Fog Level 1 Tie Mask and Halyard Anti-Fog Level 3 Tie Mask
EXAMINATION GLOVE, SPECIALTY
DISPOSABLE MEDICAL BEDDING
HALYARD ULTRA SURGICAL GOWN
Counter, sponge, surgical
SKYBREEZE LDP* Powder-Free Nitrile Exam Gloves
Halyard Purple Nitrile Max Powder-Free Exam Gloves
DERMA PRENE ISOTOUCH GREEN STERILE POWDER-FREE POLYISOPRENE SURGICAL GOVES
PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Remanufacture Medical Device