MEDICAL ACTION INDUSTRIES, INC. 306

FDA Device Registration & Listing · ARDEN, NC, US · Registration 1030451

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
1030451
FEI Number
1030451
Entity Name
MEDICAL ACTION INDUSTRIES, INC. 306
City/State/Country
ARDEN, NC, US
Establishment Address
25 HEYWOOD RD., ARDEN, NC 28704, US
Establishment Type(s)
Repack or Relabel 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
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 Tourniquet 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 Hemodialysis Kit Dialysis Administration Kit Stocking Endoscope Introducer Kit Endoscopy Kit General Surgery Tray (Kit) SurgiTrack Hip Pack Hand Pack Knee Pack Toe Nail Kit General Convenience Kit General Purpose Kit Stockinette 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 Needle 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OJF Hysterectomy Kit Obstetrics/Gynecology Class 2 884.4530 2024-09-03
CAZ Anesthesia Conduction Kit Anesthesiology Class 2 868.5140 2015-08-17
FTN Plastic Surgery And Accessories Kit General, Plastic Surgery Class 1 878.3925 2015-08-17
OFX General Purpose Dental Tray Dental Class 1 872.6640 2015-08-14
OFT Spinal Epidural Anesthesia Kit Anesthesiology Class 2 868.5120 2015-08-14
MCY Wound Dressing Kit General Hospital Class 2 880.5075 2015-08-14
GAZ Tubing, Noninvasive General Hospital Class 2 880.6740 2015-08-14
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2015-08-17
OJV Single Use Instrument Tray General, Plastic Surgery Class 1 878.4800 2015-08-14
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2015-08-14
OHR Catheter Care Tray Gastroenterology, Urology Class 2 876.5130 2015-08-14
OKH Body Fluids Barrier Kit General, Plastic Surgery Class 2 878.4040 2015-08-14
FNY Basin, Emesis General Hospital Class 1 880.6730 2015-08-14
PEZ Central Venous Catheter Dressing Change Kit General Hospital Class 2 880.5200 2015-08-14
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2017-07-21
OEQ Angiography/Angioplasty Kit Cardiovascular Class 2 870.1650 2024-09-24
OKE Port Introducer Kit General Hospital Class 2 880.5965 2016-04-01
OJJ Burn Kit Without Drug General, Plastic Surgery Class 1 878.4022 2015-08-14
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 2017-05-24
OJG Neurological Tray Neurology Class 1 882.4525 2015-08-20
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2015-08-17
MIA Needle, Spinal, Short Term Anesthesiology Class 2 868.5150 2016-08-23
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2014-03-06
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2016-03-15
OFD Catheter Introducer Kit Cardiovascular Class 2 870.1340 2015-08-14
OKG Body Fluid Clean Up Kit General, Plastic Surgery Class 2 878.4040 2015-08-14
HFX Clamp, Circumcision Obstetrics/Gynecology Class 2 884.4530 2020-12-04
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2016-11-02
FDE Laparoscopy Kit Gastroenterology, Urology Class 2 876.1500 2021-08-19
OJH Orthopedic Tray General, Plastic Surgery Class 1 878.4800 2015-08-20
NAB Gauze / Sponge,Nonresorbable For External Use General, Plastic Surgery Class 1 878.4014 2015-08-14
OFQ Anesthesia Kit Anesthesiology Class 2 868.5120 2024-09-24
OFF Central Venous Catheter Tray Cardiovascular Class 2 870.1140 2015-08-14
FQM Bandage, Elastic General Hospital Class 1 880.5075 2015-08-14
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2015-08-14
PKF D And C Tray Unknown Class N N/A 2024-09-24
OES Cardiac Catheterization Kit Cardiovascular Class 2 870.1200 2016-06-22
OIE Urine Collection Kit (Excludes Hiv Testing) Pathology Class 1 864.3250 2015-08-14
OHD Gynecological Laparoscopic Kit Obstetrics/Gynecology Class 2 884.1720 2024-07-22
OJU Skin Prep Tray General, Plastic Surgery Class 1 878.4800 2015-08-14
MAC Decontamination Kit General, Plastic Surgery Class 1 878.4014 2015-08-14
OGR Ear, Nose, And Throat Surgical Tray Ear, Nose, Throat Class 1 874.4420 2024-09-03
FKG Tray, Start/Stop (Including Contents), Dialysis Gastroenterology, Urology Class 1 876.5820 2015-08-14
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2015-12-03
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2015-08-14
OGE Epidural Anesthesia Kit Anesthesiology Class 2 868.5120 2024-09-24
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2020-05-01
GAX Tourniquet, Nonpneumatic General, Plastic Surgery Class 1 878.5900 2015-08-14
MLS Labor And Delivery Kit Obstetrics/Gynecology Class 2 884.4530 2015-08-14
LJH System, Irrigation, Urological Gastroenterology, Urology Class 2 876.5130 2016-08-18
HRX Arthroscope Orthopedic Class 2 888.1100 2016-08-18
ITG Bandage, Cast Physical Medicine Class 1 890.3025 2022-07-27
KDC Instrument, Surgical, Disposable General, Plastic Surgery Class 1 878.4800 2015-08-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2015-11-24
KKX Drape, Surgical, Antimicrobial General, Plastic Surgery Class 2 878.4370 2021-07-22
MMO Tray, Surgical, Ent Ear, Nose, Throat Class 1 874.4420 2015-08-20
NNI Container, Specimen, Non-Sterile Pathology Class 1 864.3250 2015-08-17
OFZ Blood Specimen Collection Kit (Excludes Hiv Testing) Anesthesiology Class 1 868.1100 2015-08-14
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2016-08-18
OGJ Nerve Block Tray Anesthesiology Class 2 868.5140 2015-08-14
OWL Peripheral Catheter Insertion Kit General Hospital Class 2 880.5200 2015-08-14
PWT Chemotherapy Spill Clean-Up Kit General Hospital Class 1 880.6250 2023-04-21
OHH Breast Pump Kit Obstetrics/Gynecology Class 2 884.5160 2024-09-24
OGD Custom Anesthesia Tray Anesthesiology Class 2 868.5120 2016-06-22
OHM Cesarean Section Tray Obstetrics/Gynecology Class 2 884.1720 2025-09-30
NXA Tracheotomy Care Kit Anesthesiology Class 2 868.5800 2015-08-14
BSP Needle, Conduction, Anesthetic (W/Wo Introducer) Anesthesiology Class 2 868.5150 2016-08-23
OGW Tracheostomy Kit Anesthesiology Class 2 868.5800 2015-08-14
MNL Accessories, Cleaning Brushes, For Endoscope Gastroenterology, Urology Class 1 876.1500 2015-08-17
MLT Pelvic Exam Kit Obstetrics/Gynecology Class 2 884.4530 2015-08-14
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2016-08-18
PXJ Umbilical Catheter Insertion Tray General Hospital Class 2 880.5200 2024-09-24
FFO Retractor, Self-Retaining Gastroenterology, Urology Class 1 876.4730 2024-07-22
PEV Dialysis Administration Kit Gastroenterology, Urology Class 2 876.5820 2017-06-30
FQL Stocking, Medical Support (For General Medical Purposes) General Hospital Class 1 880.5780 2017-05-24
NWU Endoscope Introducer Kit Gastroenterology, Urology Class 2 876.1500 2015-08-14
LRO General Surgery Tray General, Plastic Surgery Class 2 878.4370 2015-08-14
IPM Cover, Limb Physical Medicine Class 1 890.3025 2015-08-17
FYA Gown, Surgical General, Plastic Surgery Class 2 878.4040 2020-05-01
LWE Bone Marrow Collection/Transfusion Kit Unknown Class 2 N/A 2015-08-14
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2015-08-17
OII Arthrogram Tray Radiology Class 2 892.1650 2024-09-03
GDY Gauze/Sponge, Internal, X-Ray Detectable General, Plastic Surgery Class 1 878.4450 2015-08-14
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2016-08-18
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2016-08-23
KDT Container, Specimen Mailer And Storage, Sterile Pathology Class 1 864.3250 2016-03-10
FCN Urinary Drainage Collection Kit, For Indwelling Catheter Gastroenterology, Urology Class 2 876.5250 2016-08-03
OCT Anti Fog Solution And Accessories, Endoscopy Gastroenterology, Urology Class 2 876.1500 2015-11-24
OIB Blood And Urine Collection Kit (Excludes Hiv Testing) Pathology Class 1 864.3250 2024-09-24
OVN Suture Kit General, Plastic Surgery Class 2 878.4830 2015-08-14
LRS I.V. Start Kit General Hospital Class 2 880.5200 2015-08-14
NWT Endoscopic Cholangiogram Kit Gastroenterology, Urology Class 2 876.1500 2024-09-24
FRL Fiber, Medical, Absorbent General Hospital Class 1 880.5300 2016-11-09
OHG Circumcision Tray Obstetrics/Gynecology Class 2 884.4530 2015-08-14
OFA Cardiovascular Surgical Instruments Tray Cardiovascular Class 1 870.4500 2015-08-14
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2015-08-17
OGH Laryngoscope Kit Anesthesiology Class 1 868.5540 2024-09-24
HRP Pen, Marking, Surgical Ophthalmic Class 1 886.4570 2015-08-14

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
K910471 Baxter Healthcare Corp MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE 1991-03-08
K881095 CooperVision, Inc. KOI(TM) INSTRUMENT TRAYS 1988-04-06
K934333 3M Medical Products Group 3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE 1994-07-07
K892118 Paramount Products, Inc. NON-STERILE MASKS AND CAPS 1989-04-20
K936120 Cush Medical Products LABOR AND DELIVERY TRAY 1994-03-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0026-2020 Merit Medical Systems, Inc. 2
Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
Z-0036-2010 Alphatec Spine, Inc. 1
ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
Z-0016-2012 Deroyal Industries, Inc. Lafollette 2
DeRoyal (R) Heat/Moist Exchange, REF 83-000042, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA: Intended Use: Varies by kit; an anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.
Z-0027-2020 Merit Medical Systems, Inc. 2
Custom Procedure Kit, Vein Kit, Product Code/REF: K12T-10167, single use, RX Only, Sterile EO, UDI: (01) 00884450390580

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1030451. Last updated year: 2026. Please use registration number 1030451 when referencing this establishment in official correspondence.
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