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HemosIL Calcium Chloride 0.020M (for SynthASil SynthAFax)
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- HemosIL Calcium Chloride 0.020M (for SynthASil SynthAFax) FDA UDI
- Generic Name
- Calcium chloride coagulation reagent IVD FDA UDI
- Device Name
- HemosIL Calcium Chloride 0.020M (for SynthASil SynthAFax) FDA UDI
- Model / Reference
- 00020006900 FDA UDI
- Description
- HemosIL Calcium Chloride 0.020M (for SynthASil SynthAFax) FDA UDI
Identifiers
- Catalog Number
- 00020006900 FDA UDI
- Primary DI / UDI-DI
- 08426950087632 FDA UDI
- 510(k) Number
- K060688 FDA UDI
- FDA Product Code
- GFO FDA UDI
- GMDN Term
- Calcium chloride coagulation reagent IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7925 FDA UDI
- Commercial Distribution
- Not 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
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
No
FDA UDI
HemosIL Calcium Chloride 0.020M (for SynthASil SynthAFax) by Instrumentation Laboratory Company — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Instrumentation Laboratory Company
Sources (2)
- FDA UDI 0c5eb3b3-a0cd-438f-9223-fe55a74d04e3 38 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026