FDA.reportPublic FDA data

MEDICAL ACTION INDUSTRIES

Primary DI
10809160217092
Brand
MEDICAL ACTION INDUSTRIES
Company
MEDICAL ACTION INDUSTRIES INC.
Model
78341B
Published
2018-11-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PEVDialysis administration kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEVDialysis Administration KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160217099PackageGS120Not in Commercial Distribution
10809160217092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916021709920809160217099
1080916021709210809160217092

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis catheterization kitA collection of sterile devices and materials intended to be used for short-term (< 30 days) venous access during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It includes a nonimplantable double-lumen haemodialysis catheter, device dedicated to catheter introduction/function (e.g., introducer needle, guidewire) and includes non-dedicated supportive devices (e.g., drape, dressings, scalpel). 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

Regulatory Flags#

DUNS number
092364462
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160527665MEDICAL ACTION INDUSTRIES849602026-07-21
10809160527054Medical Action Industries78216C2026-07-14
10809160527078MEDICAL ACTION INDUSTRIES848842026-07-14
10809160527030MEDICAL ACTION INDUSTRIES848882026-07-13
10809160526866MEDICAL ACTION INDUSTRIES850202026-07-08
10809160526873MEDICAL ACTION INDUSTRIES849172026-07-08
10809160526750MEDICAL ACTION INDUSTRIES851662026-07-06
10809160526774HALYARD849182026-07-06
10809160526781HALYARD849162026-07-06
10809160231869Medical Action IndustriesLH_71171B2019-03-20
10809160476505Medical Action Industries843102025-07-09
10809160523155MEDICAL ACTION INDUSTRIES850142026-06-09
10809160226100Splash Medical Devices715622019-02-05
10809160522790Medical Action Industries851072026-06-05
10809160522806Medical Action Industries851642026-06-05
10809160522479Medical Action Industries848692026-06-03
10809160521748MEDICAL ACTION INDUSTRIES849572026-05-22
10809160433560Medical Action Industries838852024-08-23
10809160278833Medical Action Industries78898D2020-02-21
10809160107270MEDICAL ACTION INDUSTRIES807792016-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956467248CARDINAL HEALTHCardinal Health 200, LLCPEV2026-07-20
10809160520291Clear SequenceMEDICAL ACTION INDUSTRIES INC.PEV2026-04-28
10198956419100CARDINAL HEALTHCardinal Health 200, LLCPEV2026-03-24
50198956419108CARDINAL HEALTHCardinal Health 200, LLCPEV2026-03-24
10809160508428Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEV2026-01-09
20809160508425Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEV2026-01-09
10198459467608MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-08-11
40198459467609MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-08-11
10198459394973MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-07-07
40198459394974MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-07-07
10198459337536MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-05-12
40198459337537MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PEV2025-05-12
10198459329401Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2025-04-18
40198459329402Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2025-04-18
10198459283796Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2025-03-09
40198459283797Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2025-03-09
10653160998808Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.PEV2025-02-23
40653160998809Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.PEV2025-02-23
10197106795675CARDINAL HEALTHCardinal Health 200, LLCPEV2024-10-22
50197106795673CARDINAL HEALTHCardinal Health 200, LLCPEV2024-10-22
10198459149375Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-10-13
10198459149382Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-10-13
40198459149376Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-10-13
40198459149383Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-10-13
10195327571122Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-07-29
10195327594022Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-07-29
40195327571123Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-07-29
40195327594023Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-07-29
10195327653460Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-05-05
40195327653461Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PEV2024-05-05