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Thoratec® Hearmate Ii®, Sealed Outflow Graft With Bend Relief
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- THORATEC® HEARMATE II®, SEALED OUTFLOW GRAFT WITH BEND RELIEF FDA UDI
- Generic Name
- Implantable ventricular circulatory assist system outflow cannula, animal-derived FDA UDI
- Model / Reference
- 103393Y FDA UDI
Identifiers
- Catalog Number
- 103393Y FDA UDI
- Primary DI / UDI-DI
- 00813024011613 FDA UDI
- FDA Product Code
- DSQ FDA UDI
- GMDN Term
- Implantable ventricular circulatory assist system outflow cannula, animal-derived 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Implantable ventricular circulatory assist system outflow cannula, animal-derived
Thoratec® Hearmate Ii®, Sealed Outflow Graft With Bend Relief by Thoratec Corp — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable ventricular circulatory assist system outflow cannula, animal-derived.
- THORATEC® VAD, SEALED ARTERIAL CANNULA, EXTRA LONG, STRAIGHT, 18MM — Thoratec Corp · Class III
- Thoratec® HeartMate 3™ — Thoratec Corp · Class III
- THORATEC® VAD, SEALED ARTERIAL CANNULA, LONG, STRAIGHT, 14MM — Thoratec Corp · Class III
- THORATEC® VAD, SEALED ARTERIAL CANNULA, LONG, STRAIGHT, 18MM — Thoratec Corp · Class III
- THORATEC® VAD, SEALED ARTERIAL CANNULA, SHORT, STRAIGHT, 14MM — Thoratec Corp · Class III
- THORATEC® HEARTMATE II®, SEALED OUTFLOW BEND RELIEF COLLAR — Thoratec Corp · Class III
- THORATEC® HEARTMATE II®, SEALED OUTFLOW GRAFT WITH BEND RELIEF — Thoratec Corp · Class III
- THORATEC® HEARTMATE II®, SEALED OUTFLOW SHORT BEND RELIEF, 7.6CM (3 IN) — Thoratec Corp · 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 |
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Manufacturer
- Manufacturer
- Thoratec Corp
Sources (1)
- FDA UDI 97c76090-956d-40bd-a668-d40a0b75bf03 35 fields · synced May 30, 2026