FDA.reportPublic FDA data

Medical Action Industries

Primary DI
20809160345105
Brand
Medical Action Industries
Company
MEDICAL ACTION INDUSTRIES INC.
Model
80391B
Published
2021-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
OHRCatheter care tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHRCatheter Care TrayGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160345105PackageGS18In Commercial Distribution
10809160345108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916034510520809160345105
1080916034510810809160345108

GMDN Terms#

Term, Definition table
TermDefinition
Urinary catheter holderA device designed to be attached to a patient's body to hold an indwelling urinary catheter line (e.g., Foley) in place. It consists of a wrap or adhesive strip/pad placed around the patient's thigh, abdomen, or pubis. The holder includes appropriate mechanisms or attachments that can hold the tube or catheter (e.g., integrated Velcro hook, loop, clip) without creating excessive pressure on it and permitting visual inspection of the site. It is not designed to hold a urine collection bag. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
092364462
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160521748MEDICAL ACTION INDUSTRIES849572026-05-22
20809160517113MEDICAL ACTION INDUSTRIES843992026-03-23
20809160516574Medical Action Industries82274B2026-03-19
20809160016463Medical Action Industries716912016-08-20
20809160515195Clear Sequence836992026-03-06
20809160515218MEDICAL ACTION INDUSTRIES848602026-03-06
20809160515157MEDICAL ACTION INDUSTRIES847242026-03-05
20809160514938Medical Action Industries81329E2026-03-04
20809160514990Medical Action Industries76567F2026-03-04
20809160515003Medical Action Industries78304B2026-03-04
20809160515027Medical Action Industries77156B2026-03-04
20809160514754MEDICAL ACTION INDUSTRIES82438B2026-03-03
20809160514761MEDICAL ACTION INDUSTRIES82436B2026-03-03
20809160514136Medical Action Industries837402026-02-26
20809160513856Medical Action Industries822742026-02-25
20809160513924MEDICAL ACTION INDUSTRIES848192026-02-25
20809160513337MEDICAL ACTION INDUSTRIES82274C2026-02-20
20809160512521MEDICAL ACTION INDUSTRIES826092026-02-13
20809160512231MEDICAL ACTION INDUSTRIES846012026-02-11
20809160512248MEDICAL ACTION INDUSTRIES843142026-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10854913006201Intravesical Administration Kit UROGEN PHARMA LTDOHR2026-03-15
50850058254680TruAdvance™HR PHARMACEUTICALS INC.OHR2026-03-06
50850045818468TruAdvance®HR PHARMACEUTICALS INC.OHR2025-12-22
50850045818475TruAdvance®HR PHARMACEUTICALS INC.OHR2025-12-22
50850045818482TruAdvance®HR PHARMACEUTICALS INC.OHR2025-12-22
00850063139366Neil Medical Group Neil Medical GroupOHR2025-12-08
00850063139373Neil Medical Group Neil Medical GroupOHR2025-12-08
00850063139380Neil Medical Group Neil Medical GroupOHR2025-12-08
00850063139397Neil Medical Group Neil Medical GroupOHR2025-12-08
50198956214567CARDINAL HEALTHCardinal Health 200, LLCOHR2025-11-28
50850058254888TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50850058254895TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50850058254901TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50850058254918TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50850058254925TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50850058254932TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50850058254949TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50850058254956TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50850058254963TruAdvanceHR PHARMACEUTICALS INC.OHR2025-09-11
50198956094374CARDINAL HEALTHCardinal Health 200, LLCOHR2025-08-25
50850058254765TruAdvanceHR PHARMACEUTICALS INC.OHR2025-08-11
50850058254970TruAdvanceHR PHARMACEUTICALS INC.OHR2025-08-11
50850058254987TruAdvanceHR PHARMACEUTICALS INC.OHR2025-08-11
50850058254857TruAdvanceHR PHARMACEUTICALS INC.OHR2025-08-05
50850058254864TruAdvanceHR PHARMACEUTICALS INC.OHR2025-08-05
50850058254871TruAdvanceHR PHARMACEUTICALS INC.OHR2025-08-05
50850058254826TruAdvanceHR PHARMACEUTICALS INC.OHR2025-07-25
50850058254833TruAdvanceHR PHARMACEUTICALS INC.OHR2025-07-25
50850058254840TruAdvanceHR PHARMACEUTICALS INC.OHR2025-07-25
10854913006171Intravesical Administration KitUROGEN PHARMA LTDOHR2025-06-16