AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY 305

FDA Device Registration & Listing · TOANO, VA, US · Registration 1047429

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1047429
FEI Number
1047429
Entity Name
AVID MEDICAL, INC. A MEDICAL ACTION IND. COMPANY 305
City/State/Country
TOANO, VA, US
Establishment Address
9000 WESTMONT DR., STONEHOUSE COMMERCE PARK, TOANO, VA 23168, US
Establishment Type(s)
Repack or Relabel Medical Device,Manufacture Medical Device
Owner / Operator
O & M Halyard, Inc. (Owner Number: 10039033)
Owner / Operator Contact Address
1220 Old Alpharetta Rd. Ste 320, Alpharetta, GA 30005, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 SurgiTrack 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 Needle Stocking Forcep Hemodialysis Kit 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PSD Laparoscopic Gastrostomy Kit Gastroenterology, Urology Class 2 876.5980 2025-06-18
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2015-08-17
PEV Dialysis Administration Kit Gastroenterology, Urology Class 2 876.5820 2017-06-30
OJU Skin Prep Tray General, Plastic Surgery Class 1 878.4800 2015-08-14
OIB Blood And Urine Collection Kit (Excludes Hiv Testing) Pathology Class 1 864.3250 2024-09-24
OXQ Dressing Change Tray General Hospital Class 1 880.5075 2015-08-14
FTN Plastic Surgery And Accessories Kit General, Plastic Surgery Class 1 878.3925 2015-08-17
OEZ Cardiovascular Procedure Kit Cardiovascular Class 2 870.1200 2016-03-17
NWU Endoscope Introducer Kit Gastroenterology, Urology Class 2 876.1500 2015-08-14
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2017-07-21
LRS I.V. Start Kit General Hospital Class 2 880.5200 2015-08-14
OHM Cesarean Section Tray Obstetrics/Gynecology Class 2 884.1720 2025-09-30
MCZ Suture Removal Kit General, Plastic Surgery Class 1 878.4800 2015-08-14
OIP Radiology-Diagnostic Kit Radiology Class 2 892.1680 2016-06-10
OJK Eye Tray Ophthalmic Class 2 886.4790 2015-08-14
OJG Neurological Tray Neurology Class 1 882.4525 2015-08-20
OFZ Blood Specimen Collection Kit (Excludes Hiv Testing) Anesthesiology Class 1 868.1100 2015-08-14
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2015-08-17
OJF Hysterectomy Kit Obstetrics/Gynecology Class 2 884.4530 2024-09-03
OGJ Nerve Block Tray Anesthesiology Class 2 868.5140 2015-08-14
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2015-08-14
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2014-03-06
OMH Pericardial Patch To Facilitate Revision Surgeries Cardiovascular Class 2 870.3470 2024-09-03
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2016-08-23
PXJ Umbilical Catheter Insertion Tray General Hospital Class 2 880.5200 2024-09-24
OFQ Anesthesia Kit Anesthesiology Class 2 868.5120 2024-09-24
OFF Central Venous Catheter Tray Cardiovascular Class 2 870.1140 2015-08-14
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2016-08-18
OGD Custom Anesthesia Tray Anesthesiology Class 2 868.5120 2016-06-22
OES Cardiac Catheterization Kit Cardiovascular Class 2 870.1200 2016-06-22
OHD Gynecological Laparoscopic Kit Obstetrics/Gynecology Class 2 884.1720 2024-07-22
OFX General Purpose Dental Tray Dental Class 1 872.6640 2015-08-14
GAA Needle, Aspiration And Injection, Disposable General, Plastic Surgery Class 1 878.4800 2026-04-30
NWT Endoscopic Cholangiogram Kit Gastroenterology, Urology Class 2 876.1500 2024-09-24
HFW Clamp, Umbilical Obstetrics/Gynecology Class 2 884.4530 2016-08-18
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 2020-06-23
OEQ Angiography/Angioplasty Kit Cardiovascular Class 2 870.1650 2024-09-24
ITG Bandage, Cast Physical Medicine Class 1 890.3025 2022-07-27
OJV Single Use Instrument Tray General, Plastic Surgery Class 1 878.4800 2015-08-14
OII Arthrogram Tray Radiology Class 2 892.1650 2024-09-03
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 2015-08-14
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2016-08-23
FQL Stocking, Medical Support (For General Medical Purposes) General Hospital Class 1 880.5780 2017-05-24
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 2017-05-24
FKG Tray, Start/Stop (Including Contents), Dialysis Gastroenterology, Urology Class 1 876.5820 2015-08-14
OGH Laryngoscope Kit Anesthesiology Class 1 868.5540 2024-09-24
OJJ Burn Kit Without Drug General, Plastic Surgery Class 1 878.4022 2015-08-14
OGE Epidural Anesthesia Kit Anesthesiology Class 2 868.5120 2024-09-24
OJH Orthopedic Tray General, Plastic Surgery Class 1 878.4800 2015-08-20
OHG Circumcision Tray Obstetrics/Gynecology Class 2 884.4530 2015-08-14
MLT Pelvic Exam Kit Obstetrics/Gynecology Class 2 884.4530 2015-08-14
NSB Patient Personal Hygiene Kit Dental Class 1 872.6855 2015-10-27
LYV Label Or Tag, Sterile General, Plastic Surgery Class 1 878.4800 2017-07-14
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2016-08-18
HIO Sampler, Amniotic Fluid (Amniocentesis Tray) Obstetrics/Gynecology Class 1 884.1550 2015-11-24
KXG Applicator, Absorbent Tipped, Sterile General Hospital Class 1 880.6025 2015-08-14
OGS Myringotomy Procedure Kit Ear, Nose, Throat Class 2 874.3880 2018-09-24
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2015-08-17
OHH Breast Pump Kit Obstetrics/Gynecology Class 2 884.5160 2024-09-24
LJH System, Irrigation, Urological Gastroenterology, Urology Class 2 876.5130 2016-08-18
HRX Arthroscope Orthopedic Class 2 888.1100 2016-08-18
OFG Ct Biopsy Tray Cardiovascular Class 2 870.4075 2024-09-24
OVN Suture Kit General, Plastic Surgery Class 2 878.4830 2015-08-14
FTA Light, Surgical, Accessories General, Plastic Surgery Class 2 878.4580 2015-08-14
OKE Port Introducer Kit General Hospital Class 2 880.5965 2016-04-01
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2016-11-02
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2016-08-18
OKV Obstetrical Kit Obstetrics/Gynecology Class 2 884.4520 2015-08-20

Official Correspondent

Angela Bunn

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

O & M Halyard, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3002669946 Owens & Minor Distribution Inc. OM45 Sunrise, FL, US
3003924117 OWENS & MINOR DISTRIBUTION INC. OM30 Kennesaw, GA, US
1000124971 OWENS & MINOR DISTRIBUTION INC. OM65 Ontario, CA, US
2000028362 OWENS & MINOR DISTRIBUTION INC. OM87 Ashland, VA, US
3011144486 ArcRoyal uc Kells Meath, IE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21
K915446 Sun Glitz Corp. STRETCH WRAP 1992-05-06
K833120 Acme United Corp. ONE TIME COMPOUND BENZOIN TINCTURE- 1983-12-29
K870091 Avery Intl. IV SECUREMENT DEVICE USING PCCE THERMO. FILM 1987-02-04
K961683 J.J. Skinner, Inc. JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY 1996-05-10

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0015-2009 Medline Industries Inc 2
Medline Latex Free C-Section CDS-LF and C-Section Supplemental CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
Z-0016-2009 Medline Industries Inc 2
Medline Latex Free Vaginal Delivery CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
Z-0017-2009 Medline Industries Inc 2
Medline Latex Free Labor Kit & Postpartum CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
Z-0018-2009 Medline Industries Inc 2
Medline Latex Free Labor & Delivery CDS-LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
Z-0019-2009 Medline Industries Inc 2
Medline Latex Free Mom/Baby Admit Kit - LF; a single patient prescription procedure pack and disposables, including a Gerber Nuk Pacifier; Made in USA by Medline Industries, Inc., Mundelein, IL 60060

Similar Registrations

Registration Number Establishment Name Location
1061124 Sterigenics U.S., LLC Charlotte, NC, US
2029015 Sterigenics U.S., LLC Ontario, CA, US
3035642068 Honduras Kitting, S.A. Villanueva Cortes, HN
3007329020 Cardinal Health 200, LLC El Paso, TX, US
1643817 ISOMEDIX OPERATIONS INC EL PASO, TX, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1047429. Last updated year: 2026. Please use registration number 1047429 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.