FDA Registration Active 🇺🇸 United States

MEDICAL ACTION INDUSTRIES, INC. 306

Reg #: 1030451 · FEI: 1030451 · Expires 2026
Products
120
Proprietary Names
193
Establishment Types
3
Classifications
120

Registration Details

Registration Name
MEDICAL ACTION INDUSTRIES, INC. 306
Registration Number
1030451
FEI Number
1030451
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
25 HEYWOOD RD.
City
ARDEN
State
NC
ZIP
28704
Country
US

Regulatory Submissions

510(k) Number
K971645

Owner / Operator

Firm Name
O & M Halyard, Inc.
Operator Number
10039033
Address
1220 Old Alpharetta Rd. Ste 320
City
Alpharetta
State
GA
Postal Code
30005
Country
US
Correspondent
Angela L Bunn

Products

Device Name Product Code
Hysterectomy Kit OJF
Anesthesia Conduction Kit CAZ
Plastic Surgery And Accessories Kit FTN
General Purpose Dental Tray OFX
Spinal Epidural Anesthesia Kit OFT
Wound Dressing Kit MCY
Tubing, Noninvasive GAZ
Clamp, Surgical, General & Plastic Surgery GDJ
Single Use Instrument Tray OJV
Tray, Surgical, Instrument FSM
Catheter Care Tray OHR
Body Fluids Barrier Kit OKH
Basin, Emesis FNY
Central Venous Catheter Dressing Change Kit PEZ
Drape, Surgical, Exempt PUI
Angiography/Angioplasty Kit OEQ
Port Introducer Kit OKE
Burn Kit Without Drug OJJ
Forceps, Ophthalmic HNR
Neurological Tray OJG
Protector, Skin Pressure FMP
Needle, Spinal, Short Term MIA
Tray, Surgical LRP
Syringe, Irrigating (Non Dental) KYZ
Catheter Introducer Kit OFD
Body Fluid Clean Up Kit OKG
Clamp, Circumcision HFX
Scissors, General, Surgical LRW
Laparoscopy Kit FDE
Orthopedic Tray OJH
Gauze / Sponge,Nonresorbable For External Use NAB
Anesthesia Kit OFQ
Central Venous Catheter Tray OFF
Bandage, Elastic FQM
Kit, Surgical Instrument, Disposable KDD
D And C Tray PKF
Cardiac Catheterization Kit OES
Urine Collection Kit (Excludes Hiv Testing) OIE
Gynecological Laparoscopic Kit OHD
Skin Prep Tray OJU
Decontamination Kit MAC
Ear, Nose, And Throat Surgical Tray OGR
Tray, Start/Stop (Including Contents), Dialysis FKG
Electrode, Electrocardiograph DRX
Tourniquet, Nonpneumatic GAX
Epidural Anesthesia Kit OGE
Gown, Surgical FYA
Labor And Delivery Kit MLS
System, Irrigation, Urological LJH
Arthroscope HRX
Bandage, Cast ITG
Instrument, Surgical, Disposable KDC
Electrosurgical, Cutting & Coagulation & Accessories GEI
Drape, Surgical, Antimicrobial KKX
Tray, Surgical, Ent MMO
Container, Specimen, Non-Sterile NNI
Blood Specimen Collection Kit (Excludes Hiv Testing) OFZ
Stopcock, I.V. Set FMG
Nerve Block Tray OGJ
Peripheral Catheter Insertion Kit OWL
Chemotherapy Spill Clean-Up Kit PWT
Breast Pump Kit OHH
Custom Anesthesia Tray OGD
Cesarean Section Tray OHM
Tracheotomy Care Kit NXA
Needle, Conduction, Anesthetic (W/Wo Introducer) BSP
Tracheostomy Kit OGW
Accessories, Cleaning Brushes, For Endoscope MNL
Pelvic Exam Kit MLT
Wire, Guide, Catheter DQX
Umbilical Catheter Insertion Tray PXJ
Retractor, Self-Retaining FFO
Dialysis Administration Kit PEV
Stocking, Medical Support (For General Medical Purposes) FQL
Endoscope Introducer Kit NWU
General Surgery Tray LRO
Cover, Limb IPM
Bone Marrow Collection/Transfusion Kit LWE
Tape, Measuring, Rulers And Calipers FTY
Arthrogram Tray OII
Gauze/Sponge, Internal, X-Ray Detectable GDY
Tubes, Gastrointestinal (And Accessories) KNT
Needle, Hypodermic, Single Lumen FMI
Container, Specimen Mailer And Storage, Sterile KDT
Urinary Drainage Collection Kit, For Indwelling Catheter FCN
Anti Fog Solution And Accessories, Endoscopy OCT
Blood And Urine Collection Kit (Excludes Hiv Testing) OIB
Suture Kit OVN
I.V. Start Kit LRS
Endoscopic Cholangiogram Kit NWT
Fiber, Medical, Absorbent FRL
Circumcision Tray OHG
Cardiovascular Surgical Instruments Tray OFA
Tape And Bandage, Adhesive KGX
Laryngoscope Kit OGH
Pen, Marking, Surgical HRP
Bladder Irrigation Kit PPA
Tray, Biopsy, Without Biopsy Instruments FCH
Patient Personal Hygiene Kit NSB
Cardiovascular Procedure Kit OEZ
Sampler, Amniotic Fluid (Amniocentesis Tray) HIO
Set, Administration, Intravascular FPA
Wrap, Sterilization FRG
Radiology-Diagnostic Kit OIP
Dressing Change Tray OXQ
Eye Tray OJK
Media, Coupling, Ultrasound MUI
Pap Smear Kit OHL
Laparoscopic Gastrostomy Kit PSD
Speculum, Vaginal, Metal HDF
Instrument, Manual, Surgical, General Use MDM
Clamp, Umbilical HFW
Myringotomy Procedure Kit OGS
Light, Surgical, Accessories FTA
Phlebotomy Blood Collection Kit OFM
Counter, Sponge, Surgical LWH
Ct Biopsy Tray OFG
Obstetrical Kit OKV
Label Or Tag, Sterile LYV
Suture Removal Kit MCZ

Proprietary Names

Hysterectomy kit Anesthesia Conduction Kit Plastic Surgery and Accessories Kit NICU Oral Care Kit Oral Care Kit General Purpose Dental Tray Spinal Epidural Anesthesia Kit Epidural Kit Wound Dressing Kit Decubitus Treatment Kit Tubing Surgical Procedure Clamp Towel Clamp OJV / Single use instrument tray Instrument Tray Foam Instrument Pouch Needle Counter/Holder Catheter Care Tray Universal Precautions Kit Maximum Barrier Kit Body Fluid Barrier Kit Barrier Kit Sterile Bowl Basin Kit CENTRAL LINE DRESSING CHANGE KIT VAD DRESSING CHANGE KIT PICC DRESSING CHANGE KIT CVC DRESSING CHANGE KIT OR Towel Surgical Drape Magnetic Instrument Drape CARDIOVASCULAR Port introducer kit Burn kit without Drug Forcep Neurological Tray Lambswool Specialist Padding Skin Protector Adhesive Felt Moleskin Needle, Spinal SurgiTrack Instrument Tray Liner Surgical Tray Irrigation Syringe Catheter Introducer Kit Body Fluid Clean Up Kit Spill Kit Biohazard Spill Kit CLAMP, CIRCUMCISION Shears Endoscope cleaning kit Orthopedic Kit Tube Gauze Bandage Roll Gauze External Gauze Sponge Fluff Gauze Gauze Anesthesia kit Central Venous Catheter Tray Bandage Gauze Roll Elastic Bandage Disposable Instrument Kit D and C tray Cardiac Catheterization Kit Urine Collection Kit (excludes HIV testing) Gynecological Laparoscopic Kit Skin Prep Tray Chemo Spill Kit Decontamination Kit Clean- up Kit Cyta Kit Ear, nose, and throat surgical tray Hemodialysis Kit Dialysis Administration Kit (Start/Stop) Dialysis Kit TRAY, START/STOP (INCLUDING CONTENTS), DIALYSIS Electrode Kit Alarm Kit Tourniquet Epidural anesthesia kit Gown Tray Labor and Delivery Kit L&D Kit Extension Set Stockinette Single Use Surgical Instruments: Staple Remover, Scalpel, Forceps, Scissor, Needle Holder, Hemostat Disposable Instrument Cautery Tip Cleaner Drape RSV Kit ENT Surgery Kit CONTAINER, SPECIMEN, NON-STERILE Blood Culture Kit Blood Specimen Collection Kit (excludes HIV testing) Venipuncture Kit Lab Draw Kit Blood Specimen Collection Kit EXT Set Universal Block Kit Nerve Block Tray Neurology Procedure Tray Pain Kit Port Access Kit Peripheral Catheter Insertion Kit PICC Kit Quick Kit VAD Access Kit Chemo Spill Breast pump kit Custom Anesthesia Tray Cesarean section tray Trach Care Kit Tracheostomy Care Kit Needle ER Trach Kit Tracheostomy Kit Trach Kit Endoscope Accessory and Cleaning Kit Endo Transport Pad Endoscope Brushes and Cleaning Accessories Pelvic Exam Kit Guide Wire Umbilical catheter insertion tray Retractor, Self-Retaining Dialysis Administration Kit Stocking Endoscope Introducer Kit Endoscopy Kit General Surgery Tray (Kit) Hip Pack Hand Pack Knee Pack Toe Nail Kit General Convenience Kit General Purpose Kit Gown Pack Bone Marrow Collection Kit Measuring Tape Lesion Measure Arthrogram tray Lap Sponge Internal X-Ray Gauze Endoscopic Sponge Specialty Sponge Vaginal Sponge Feeding Tube Sterile Specimen Container Urinary Cath Care Kit Urinary Collection Kit for Foley Anti Fog Solution Blood and urine collection kit (excludes HIV testing) Suture / Laceration Kit Wound Closure Kit ED/ER Suture Kit IV Start Kit GASTROENTEROLOGY-UROLOGY Medical absorbent fiber Circumcision Kit Cardiovascular Surgical Instruments Tray Chest Tube Kit Tape Laryngoscope kit Surgeon's Marking Pen Surgical Marking Pen Bladder Irrigation Kit TRAY, BIOPSY, WITHOUT BIOPSY INSTRUMENTS Patient Personal Hygiene Kit Patient Admission Kit ICU Hygiene Kit Cardiovascular Procedure Kit Amniocentesis Kit IV set Radiology Diagnostic Kit Arthrogram Kit Dressing Change Kit Eye Kit Ultrasound Lubricant / Gel Pap Smear Kit laparoscopic gastrostomy kit Uterine Sound Suture Bag Sterile Cord Clamp Myringotomy Procedure Kit Surgical Light Shield Light Shield Pack Phlebotomy Blood Collection Kit Surgical Sponge Counter CT biopsy tray Obstetrical Kit Label SUTURE REMOVAL KIT

Establishment Types

Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device