Identity
- Trade Name
- HEPtrac® FDA UDI
- Generic Name
- Coagulation timer IVD FDA UDI
- Device Name
- DEVICE 313-51 HEPTRAC ELEC QLT CNTRL CEM FDA UDI
- Model / Reference
- 313-51 FDA UDI
- Description
- DEVICE 313-51 HEPTRAC ELEC QLT CNTRL CEM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994615633 FDA UDI
- 510(k) Number
- K981815 FDA UDI
- FDA Product Code
- JPA FDA UDI
- GMDN Term
- Coagulation timer IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5425 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Coagulation timer IVD
HEPtrac® by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Coagulation timer IVD.
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Cleared under the same submission
K981815 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 74190b82-e470-495c-89e8-d5d73a92687d 36 fields · synced May 30, 2026