Impella RP Flex with SmartAssist

GUDID 00813502012811

Abiomed, Inc.

Intracardiac circulatory assist axial-pump catheter
Primary Device ID00813502012811
NIH Device Record Key966a3eaf-e5f9-4f6e-ae48-7389f9d1085a
Commercial Distribution StatusIn Commercial Distribution
Brand NameImpella RP Flex with SmartAssist
Version Model Number1000323
Company DUNS050636737
Company NameAbiomed, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
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
GS100813502012811 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PYXTemporary Non-Roller Type Right Heart Support Blood Pump

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-23
Device Publish Date2023-02-15

Devices Manufactured by Abiomed, Inc.

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00813502012736 - Impella2023-11-06 ABMD Intro Kit, 14Fr x Long, Pkgd US
00813502013474 - Impella2023-11-06 Kit, 14Fr Introducer, 13cm and 25cm
00813502011388 - Impella2023-08-08 Impella CP C7 w V3 GWRU Set, US
00813502011401 - Impella2023-08-08 Optical, AIC, Impella Connect, Pkgd, US
00813502011876 - Impella2023-08-08 Pump 371 14F LT CMR Set
00813502012279 - Impella2023-08-08 Pump 381 Pump Set (US)
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