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Impella

FDA UDI

Class III (US FDA UDI)

by Abiomed, Inc.

Identity

Trade Name
Impella FDA UDI
Generic Name
Infusion pump cassette FDA UDI
Device Name
Purge Cassette Gen02, 5-Packs FDA UDI
Model / Reference
1000200 FDA UDI
Description
Purge Cassette Gen02, 5-Packs FDA UDI

Identifiers

Catalog Number
1000200 FDA UDI
Primary DI / UDI-DI
00813502012477 FDA UDI
PMA Number
P140003 FDA UDI
P170011 FDA UDI
FDA Product Code
OZD FDA UDI
PYX FDA UDI
GMDN Term
Infusion pump cassette FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
870.4360 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: Infusion pump cassette

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

Similar devices

Also classified as Infusion pump cassette.

Cleared under the same submission

P140003 also covers:

P170011 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 065e6ecd-abe9-43b5-9df1-d9518ba11f85 35 fields · synced May 30, 2026