FDA.reportPublic FDA data

Medical Action Industries

Primary DI
10809160135464
Brand
Medical Action Industries
Company
MEDICAL ACTION INDUSTRIES INC.
Model
57617G
Published
2017-03-21
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
OWLPeripheral catheter insertion kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWLPeripheral Catheter Insertion KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160135461PackageGS110Not in Commercial Distribution
10809160135464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916013546120809160135461
1080916013546410809160135464

GMDN Terms#

Term, Definition table
TermDefinition
Central venous catheterization kit, short-termA collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and 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
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
10809160188736Medical Action Industries781402018-04-13
10809160220733Medical Action Industries78521B2018-12-11
10809160272022Medical Action Industries789572019-11-21
10809160521410MEDICAL ACTION INDUSTRIES848532026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956266667CARDINAL HEALTHCardinal Health 200, LLCOWL2025-11-25
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10198956067981CARDINAL HEALTHCardinal Health 200, LLCOWL2025-05-05
10198956048850CARDINAL HEALTHCardinal Health 200, LLCOWL2025-04-17
10198956033917CARDINAL HEALTHCardinal Health 200, LLCOWL2025-04-09
10198956024274CARDINAL HEALTHCardinal Health 200, LLCOWL2025-03-31
10198956012912CARDINAL HEALTHCardinal Health 200, LLCOWL2025-03-25
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10197106953310CARDINAL HEALTHCardinal Health 200, LLCOWL2025-02-18
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10197106650776CARDINAL HEALTHCardinal Health 200, LLCOWL2024-06-10
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10197106611067CARDINAL HEALTHCardinal Health 200, LLCOWL2024-04-11
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10197106499498CARDINAL HEALTHCardinal Health 200, LLCOWL2023-12-06
10197106488959CARDINAL HEALTHCardinal Health 200, LLCOWL2023-11-28
10197106427477CARDINAL HEALTHCardinal Health 200, LLCOWL2023-11-27
10197106472781CARDINAL HEALTHCardinal Health 200, LLCOWL2023-10-31
10197106442197CARDINAL HEALTHCardinal Health 200, LLCOWL2023-09-19