Identity
- Trade Name
- .02M Calcium Chloride FDA UDI
- Generic Name
- Calcium chloride coagulation reagent IVD FDA UDI
- Model / Reference
- CR-109 FDA UDI
Identifiers
- Catalog Number
- CR-109 FDA UDI
- Primary DI / UDI-DI
- 00817869020007 FDA UDI
- 510(k) Number
- K902458 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Calcium chloride coagulation reagent IVD
.02M Calcium Chloride by Analytical Control Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Calcium chloride coagulation reagent IVD.
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- Calcium chloride 0.025M (M/40) — HYPHEN BIOMED
- Calcium Chloride Solution — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Calcium chloride 0.025M (M/40) — HYPHEN BIOMED
- IDG/Sanzay — IDG/SANZAY Corporation · Class II
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
- Analytical Control Systems
Sources (1)
- FDA UDI c5e24d84-b395-495f-9bf6-0673278c3824 34 fields · synced May 30, 2026