Identity
- Trade Name
- TEG HEMOSTASIS SYSTEM FDA UDI
- Generic Name
- Calcium chloride coagulation reagent IVD FDA UDI
- Device Name
- CALCIUM CHLORIDE, 0.2M, 5 ML FDA UDI
- Model / Reference
- 07-012 FDA UDI
- Description
- CALCIUM CHLORIDE, 0.2M, 5 ML FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10812747018043 FDA UDI
- FDA Product Code
- JPA FDA UDI
- GMDN Term
- Calcium chloride coagulation reagent 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 5 Milliliter FDA UDI
Category: Calcium chloride coagulation reagent IVD
Teg Hemostasis System by Haemonetics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Calcium chloride coagulation reagent IVD.
- Calcium chloride 0.025M (M/40) — HYPHEN BIOMED
- TriniCLOT™ Calcium Chloride 0.025M — TCOAG IRELAND LIMITED · Class II
- Thermo Scientific Pacific Hemostasis® — Fisher Diagnostics · Class II
- Calcium Chloride — Bio/Data Corp. · Class II
- Calcium chloride 0.025M (M/40) — HYPHEN BIOMED
- Calcium Chloride Solution — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- .02M Calcium Chloride — Analytical Control Systems · Class II
- Calcium chloride 0.025M (M/40) — HYPHEN BIOMED
Cleared under the same submission
K993678 also covers:
- 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
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Haemonetics Corporation
Sources (1)
- FDA UDI a6958339-a5ae-45c1-87a1-b6af9fcba261 36 fields · synced Jun 6, 2026