← Back to catalogue

HeartWare® Battery

FDA UDI

Class III (US FDA UDI)

by Heartware Inc.

Identity

Trade Name
HeartWare® Battery FDA UDI
Generic Name
Implantable ventricular circulatory assist system FDA UDI
Model / Reference
1650DE FDA UDI

Identifiers

Catalog Number
1650DE FDA UDI
Primary DI / UDI-DI
00888707005708 FDA UDI
PMA Number
P100047 FDA UDI
FDA Product Code
DSQ FDA UDI
GMDN Term
Implantable ventricular circulatory assist system FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

HeartWare® Battery by Heartware Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

P100047 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Heartware Inc.

Sources (1)

  • FDA UDI 2082758b-d936-4632-96cc-3e793e4115af 35 fields · synced May 30, 2026