FDA Registration
Active
🇺🇸 United States
AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY 305
Reg #: 1047429
·
FEI: 1047429
·
Expires 2026
Products
77
Proprietary Names
109
Establishment Types
4
Classifications
77
Registration Details
- Registration Name
- AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY 305
- Registration Number
- 1047429
- FEI Number
- 1047429
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9000 WESTMONT DR., STONEHOUSE COMMERCE PARK
- City
- TOANO
- State
- VA
- ZIP
- 23168
- Country
- US
Regulatory Submissions
- 510(k) Number
- K854816
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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laparoscopic Gastrostomy Kit | PSD | Class 2 | Gastroenterology, Urology | No | 2025-06-18 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2015-08-17 |
| Dialysis Administration Kit | PEV | Class 2 | Gastroenterology, Urology | No | 2017-06-30 |
| Skin Prep Tray | OJU | Class 1 | General, Plastic Surgery | No | 2015-08-14 |
| Blood And Urine Collection Kit (Excludes Hiv Testing) | OIB | Class 1 | Pathology | No | 2024-09-24 |
| Dressing Change Tray | OXQ | Class 1 | General Hospital | No | 2015-08-14 |
| Plastic Surgery And Accessories Kit | FTN | Class 1 | General, Plastic Surgery | No | 2015-08-17 |
| Cardiovascular Procedure Kit | OEZ | Class 2 | Cardiovascular | No | 2016-03-17 |
| Endoscope Introducer Kit | NWU | Class 2 | Gastroenterology, Urology | No | 2015-08-14 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2017-07-21 |
| I.V. Start Kit | LRS | Class 2 | General Hospital | No | 2015-08-14 |
| Cesarean Section Tray | OHM | Class 2 | Obstetrics/Gynecology | No | 2025-09-30 |
| Suture Removal Kit | MCZ | Class 1 | General, Plastic Surgery | No | 2015-08-14 |
| Radiology-Diagnostic Kit | OIP | Class 2 | Radiology | No | 2016-06-10 |
| Eye Tray | OJK | Class 2 | Ophthalmic | No | 2015-08-14 |
| Neurological Tray | OJG | Class 1 | Neurology | No | 2015-08-20 |
| Blood Specimen Collection Kit (Excludes Hiv Testing) | OFZ | Class 1 | Anesthesiology | No | 2015-08-14 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2015-08-17 |
| Hysterectomy Kit | OJF | Class 2 | Obstetrics/Gynecology | No | 2024-09-03 |
| Nerve Block Tray | OGJ | Class 2 | Anesthesiology | No | 2015-08-14 |
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2015-08-14 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2014-03-06 |
| Pericardial Patch To Facilitate Revision Surgeries | OMH | Class 2 | Cardiovascular | No | 2024-09-03 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2016-08-23 |
| Umbilical Catheter Insertion Tray | PXJ | Class 2 | General Hospital | No | 2024-09-24 |
| Anesthesia Kit | OFQ | Class 2 | Anesthesiology | No | 2024-09-24 |
| Central Venous Catheter Tray | OFF | Class 2 | Cardiovascular | No | 2015-08-14 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2016-08-18 |
| Custom Anesthesia Tray | OGD | Class 2 | Anesthesiology | No | 2016-06-22 |
| Cardiac Catheterization Kit | OES | Class 2 | Cardiovascular | No | 2016-06-22 |
| Gynecological Laparoscopic Kit | OHD | Class 2 | Obstetrics/Gynecology | No | 2024-07-22 |
| General Purpose Dental Tray | OFX | Class 1 | Dental | No | 2015-08-14 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2026-04-30 |
| Endoscopic Cholangiogram Kit | NWT | Class 2 | Gastroenterology, Urology | No | 2024-09-24 |
| Clamp, Umbilical | HFW | Class 2 | Obstetrics/Gynecology | No | 2016-08-18 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2020-06-23 |
| Angiography/Angioplasty Kit | OEQ | Class 2 | Cardiovascular | No | 2024-09-24 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 2022-07-27 |
| Single Use Instrument Tray | OJV | Class 1 | General, Plastic Surgery | No | 2015-08-14 |
| Arthrogram Tray | OII | Class 2 | Radiology | No | 2024-09-03 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2015-08-14 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2016-08-23 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | Class 1 | General Hospital | No | 2017-05-24 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2017-05-24 |
| Tray, Start/Stop (Including Contents), Dialysis | FKG | Class 1 | Gastroenterology, Urology | No | 2015-08-14 |
| Laryngoscope Kit | OGH | Class 1 | Anesthesiology | No | 2024-09-24 |
| Burn Kit Without Drug | OJJ | Class 1 | General, Plastic Surgery | No | 2015-08-14 |
| Epidural Anesthesia Kit | OGE | Class 2 | Anesthesiology | No | 2024-09-24 |
| Orthopedic Tray | OJH | Class 1 | General, Plastic Surgery | No | 2015-08-20 |
| Circumcision Tray | OHG | Class 2 | Obstetrics/Gynecology | No | 2015-08-14 |
| Pelvic Exam Kit | MLT | Class 2 | Obstetrics/Gynecology | No | 2015-08-14 |
| Patient Personal Hygiene Kit | NSB | Class 1 | Dental | No | 2015-10-27 |
| Label Or Tag, Sterile | LYV | Class 1 | General, Plastic Surgery | No | 2017-07-14 |
| Stopcock, I.V. Set | FMG | Class 2 | General Hospital | No | 2016-08-18 |
| Sampler, Amniotic Fluid (Amniocentesis Tray) | HIO | Class 1 | Obstetrics/Gynecology | No | 2015-11-24 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2015-08-14 |
| Myringotomy Procedure Kit | OGS | Class 2 | Ear, Nose, Throat | No | 2018-09-24 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2015-08-17 |
| Breast Pump Kit | OHH | Class 2 | Obstetrics/Gynecology | No | 2024-09-24 |
| System, Irrigation, Urological | LJH | Class 2 | Gastroenterology, Urology | No | 2016-08-18 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2016-08-18 |
| Ct Biopsy Tray | OFG | Class 2 | Cardiovascular | No | 2024-09-24 |
| Suture Kit | OVN | Class 2 | General, Plastic Surgery | No | 2015-08-14 |
| Light, Surgical, Accessories | FTA | Class 2 | General, Plastic Surgery | No | 2015-08-14 |
| Port Introducer Kit | OKE | Class 2 | General Hospital | No | 2016-04-01 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2016-11-02 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2016-08-18 |
| Obstetrical Kit | OKV | Class 2 | Obstetrics/Gynecology | No | 2015-08-20 |
| Ear, Nose, And Throat Surgical Tray | OGR | Class 1 | Ear, Nose, Throat | No | 2024-09-03 |
| Labor And Delivery Kit | MLS | Class 2 | Obstetrics/Gynecology | No | 2015-08-14 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2020-05-01 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2017-03-02 |
| Needle, Spinal, Short Term | MIA | Class 2 | Anesthesiology | No | 2016-08-23 |
| D And C Tray | PKF | Class N | Unknown | No | 2024-09-24 |
| Tray, Biopsy, Without Biopsy Instruments | FCH | Class 1 | Gastroenterology, Urology | No | 2024-09-24 |
| Peripheral Catheter Insertion Kit | OWL | Class 2 | General Hospital | No | 2015-08-14 |
| Laparoscopy Kit | FDE | Class 2 | Gastroenterology, Urology | No | 2021-08-19 |
Proprietary Names
laparoscopic gastrostomy kit
Tape
Hemodialysis Kit
Dialysis Administration Kit
Skin Prep Tray
Blood and urine collection kit (excludes HIV testing)
Dressing Change Kit
Plastic Surgery and Accessories Kit
Cardiovascular Procedure Kit
Endoscope Introducer Kit
Endoscopy Kit
OR Towel
Surgical Drape
Magnetic Instrument Drape
IV Start Kit
Cesarean section tray
SUTURE REMOVAL KIT
Radiology Diagnostic Kit
Arthrogram Kit
Eye Kit
Neurological Tray
Blood Culture Kit
Blood Specimen Collection Kit (excludes HIV testing)
Venipuncture Kit
Lab Draw Kit
Blood Specimen Collection Kit
CONTAINER, SPECIMEN, NON-STERILE
Hysterectomy kit
Universal Block Kit
Nerve Block Tray
Neurology Procedure Tray
Pain Kit
General Surgery Tray (Kit)
SurgiTrack
Hip Pack
Hand Pack
Knee Pack
Toe Nail Kit
General Convenience Kit
General Purpose Kit
Instrument Tray Liner
Surgical Tray
Pericardial patch to facilitate revision surgeries
Needle
Umbilical catheter insertion tray
Anesthesia kit
Central Venous Catheter Tray
Feeding Tube
Custom Anesthesia Tray
Cardiac Catheterization Kit
Gynecological Laparoscopic Kit
NICU Oral Care Kit
Oral Care Kit
General Purpose Dental Tray
GASTROENTEROLOGY-UROLOGY
Sterile Cord Clamp
Uterine Sound
CARDIOVASCULAR
Stockinette
OJV / Single use instrument tray
Arthrogram tray
Tubing
Stocking
Forcep
Dialysis Administration Kit (Start/Stop)
Dialysis Kit
TRAY, START/STOP (INCLUDING CONTENTS), DIALYSIS
Laryngoscope kit
Burn kit without Drug
Epidural anesthesia kit
Orthopedic Kit
Circumcision Kit
Pelvic Exam Kit
Patient Personal Hygiene Kit
Patient Admission Kit
ICU Hygiene Kit
Label
EXT Set
Amniocentesis Kit
Myringotomy Procedure Kit
Anesthesia Conduction Kit
Breast pump kit
Extension Set
CT biopsy tray
Suture / Laceration Kit
Wound Closure Kit
ED/ER Suture Kit
Surgical Light Shield
Light Shield Pack
Port introducer kit
Shears
Guide Wire
Obstetrical Kit
Ear, nose, and throat surgical tray
Labor and Delivery Kit
L&D Kit
Gown Tray
IV set
Needle, Spinal
D and C tray
TRAY, BIOPSY, WITHOUT BIOPSY INSTRUMENTS
Port Access Kit
Peripheral Catheter Insertion Kit
PICC Kit
Quick Kit
VAD Access Kit
Endoscope cleaning kit
Adapter, Large
Gown Pack
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Remanufacture Medical Device