Abiomed Impella CP 14Fr Introducer Kit

GUDID 00813502011692

Abiomed Impella CP 14Fr Introducer Kit, Long (25cm)

Abiomed, Inc.

Vascular catheter introduction set, nonimplantable
Primary Device ID00813502011692
NIH Device Record Key848543f9-e7c4-4c28-bba3-ae739ae0c0de
Commercial Distribution StatusIn Commercial Distribution
Brand NameAbiomed Impella CP 14Fr Introducer Kit
Version Model Number0052-3053
Company DUNS050636737
Company NameAbiomed, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100813502011692 [Primary]

FDA Product Code

DYBIntroducer, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-19
Device Publish Date2026-03-11

On-Brand Devices [Abiomed Impella CP 14Fr Introducer Kit ]

00813502011692Abiomed Impella CP 14Fr Introducer Kit, Long (25cm)
00813502011685Abiomed Impella CP 14Fr Introducer Kit, short (13cm)

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