Identity
- Trade Name
- TEG5000 HEMOSTASIS SYSTEM FDA UDI
- Generic Name
- Coagulation analyser IVD, laboratory FDA UDI
- Device Name
- DISPOSABLE CUPS & PINS, CLEAR FDA UDI
- Model / Reference
- 6211 FDA UDI
- Description
- DISPOSABLE CUPS & PINS, CLEAR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20812747018132 FDA UDI
- 510(k) Number
- K993678 FDA UDI
- FDA Product Code
- JPA FDA UDI
- GMDN Term
- Coagulation analyser IVD, laboratory 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
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
Yes
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
No
FDA UDI
Category: Coagulation analyser IVD, laboratory
Teg5000 Hemostasis System by Haemonetics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K993678 also covers:
- TEG HEMOSTASIS SYSTEM — HAEMONETICS CORPORATION
- TEG5000 — HAEMONETICS CORPORATION
- TEG5000 — HAEMONETICS CORPORATION
- TEG5000 — HAEMONETICS CORPORATION
- TEG5000 HEMOSTASIS ANALYZER — HAEMONETICS CORPORATION
- TEG5000 HEMOSTASIS ANALYZER — HAEMONETICS CORPORATION
- TEG5000 HEMOSTASIS SYSTEM — HAEMONETICS CORPORATION
- TEG5000 HEMOSTASIS SYSTEM — HAEMONETICS CORPORATION
- TEG5000 HEMOSTASIS SYSTEM — HAEMONETICS CORPORATION
- TEG5000 HEMOSTASIS SYSTEM — HAEMONETICS CORPORATION
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
- Haemonetics Corporation
Sources (1)
- FDA UDI cc61f820-422e-48df-822a-42fecd80c364 35 fields · synced Jun 8, 2026