Identity
- Trade Name
- HMS PLUS FDA UDI
- Generic Name
- Coagulation timer IVD FDA UDI
- Device Name
- INSTRUMENT 30514 HMS PLUS 110V EN FDA UDI
- Model / Reference
- 30514 FDA UDI
- Description
- INSTRUMENT 30514 HMS PLUS 110V EN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00673978698793 FDA UDI
- 510(k) Number
- K894317 FDA UDI
- FDA Product Code
- JOX FDA UDI
- GMDN Term
- Coagulation timer IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5680 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
Hms Plus by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K894317 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 d90d43b1-6cf8-4d1f-a07f-92524b9a5080 36 fields · synced May 30, 2026