Identity
- Trade Name
- HeartWare® Shower Bag FDA UDI
- Generic Name
- Artificial heart, temporary FDA UDI
- Model / Reference
- 2000US FDA UDI
Identifiers
- Catalog Number
- 2000US FDA UDI
- Primary DI / UDI-DI
- 00888707000031 FDA UDI
- FDA Product Code
- DSQ FDA UDI
- GMDN Term
- Artificial heart, temporary FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Artificial heart, temporary
HeartWare® Shower Bag by Heartware Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Artificial heart, temporary.
- USB Flash Drive — Heartware Inc. · Class III
- HeartWare® Shoulder Pack — Heartware Inc. · Class III
- HeartWare® Battery Charger — Heartware Inc. · Class III
- HeartWare® Waist Pack — Heartware Inc. · Class III
- Patient Pack — Heartware Inc. · Class III
- Explant Kit — Heartware Inc. · Class III
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Heartware Inc.
Sources (1)
- FDA UDI 06ad0f58-f6ba-4362-b5bb-7a96c38a75a2 33 fields · synced Jun 8, 2026