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Impella

FDA UDI

Class III (US FDA UDI)

by Abiomed, Inc.

Identity

Trade Name
Impella FDA UDI
Generic Name
Intracardiac circulatory assist axial-pump catheter FDA UDI
Device Name
Impella 5.5 with Smart Assist S2 Set, US FDA UDI
Model / Reference
1000100 FDA UDI
Description
Impella 5.5 with Smart Assist S2 Set, US FDA UDI

Identifiers

Catalog Number
1000100 FDA UDI
Primary DI / UDI-DI
00813502012828 FDA UDI
PMA Number
P140003 FDA UDI
FDA Product Code
OZD FDA UDI
GMDN Term
Intracardiac circulatory assist axial-pump catheter FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Intracardiac circulatory assist axial-pump catheter

Impella by Abiomed, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intracardiac circulatory assist axial-pump catheter.

Cleared under the same submission

P140003 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abiomed, Inc.

Sources (1)

  • FDA UDI 669aa820-b724-4730-b4be-98daf0d07558 35 fields · synced May 30, 2026