FDA.report

Hackensack

Primary DI
20809160363369
Brand
Hackensack
Company
MEDICAL ACTION INDUSTRIES INC.
Model
81721C
Published
2021-11-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
PEZCentral venous catheter dressing change kit

Product Code Classifications

CodeDeviceSpecialtyClass
PEZCentral Venous Catheter Dressing Change KitGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20809160363369PackageGS120In Commercial Distribution
10809160363362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080916036336920809160363369
1080916036336210809160363362

GMDN Terms

TermDefinition
Arterial/central venous catheterization support/maintenance kit, non-medicatedA collection of devices intended to support the catheterization procedure of an artery and/or central vein (large veins of the upper body), and/or to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Primarily intended to be used at the patient’s bedside, the kit includes devices such as: personal protective equipment (PPE), drapes, disinfectant wipes, dressings, needles, syringes, tourniquets, ultrasound transducer cover, coupling gel, sharps container, and saline solution; neither the catheter, catheter introduction device, nor pharmaceuticals are included. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

Sterilization Methods

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

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20809160514136Medical Action Industries837402026-02-26
20809160513856Medical Action Industries822742026-02-25
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20809160512521MEDICAL ACTION INDUSTRIES826092026-02-13
20809160512231MEDICAL ACTION INDUSTRIES846012026-02-11
20809160512248MEDICAL ACTION INDUSTRIES843142026-02-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50198956390322CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-03-23
50198956412161CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-03-23
50198956348330CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-03-19
50198956391862CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-03-19
50198956408799CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-03-10
20809160515195Clear SequenceMEDICAL ACTION INDUSTRIES INC.PEZ2026-03-06
20809160514990Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEZ2026-03-04
50198956372885CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-03-02
20809160513924MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PEZ2026-02-25
50198956348323CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-02-23
50198956339116CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-02-13
20809160512521MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PEZ2026-02-13
20809160512231MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PEZ2026-02-11
20809160512248MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PEZ2026-02-11
20809160512262MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PEZ2026-02-11
20809160511852MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PEZ2026-02-09
50198956339987CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-02-02
50198956322347CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-01-29
20809160510541MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PEZ2026-01-29
20809160508609Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEZ2026-01-13
20809160507619Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEZ2026-01-06
50198956269512CARDINAL HEALTHCardinal Health 200, LLCPEZ2026-01-05
20809160507206Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEZ2025-12-22
50198956269352CARDINAL HEALTHCardinal Health 200, LLCPEZ2025-12-19
20809160506858Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEZ2025-12-18
50198956236927CARDINAL HEALTHCardinal Health 200, LLCPEZ2025-12-17
20809160505844Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEZ2025-12-09
20809160505905Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEZ2025-12-09
20809160505578MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PEZ2025-12-04
20809160505356Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PEZ2025-12-02