Identity
- Trade Name
- HemoTemp FDA UDI
- Generic Name
- Medical product temperature point indicator, thermochemical FDA UDI
- Device Name
- Blood Bag Temperature Monitor FDA UDI
- Model / Reference
- 2000 FDA UDI
- Description
- Blood Bag Temperature Monitor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10815236021050 FDA UDI
- FDA Product Code
- KSE FDA UDI
- GMDN Term
- Medical product temperature point indicator, thermochemical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9700 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical product temperature point indicator, thermochemical
HemoTemp by Lcr Hallcrest, Llc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- HEATmarker® Time-Temperature Indicators: CT3 — Temptime Corporation · Class II
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- HEATmarker® Time-Temperature Indicators: CT36 — Temptime Corporation · Class II
- HEATmarker® Time-Temperature Indicators: CT2 — Temptime 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
- Lcr Hallcrest, Llc.
Sources (1)
- FDA UDI 1903528d-8bb2-4dc1-936c-6cfaf7b03ead 34 fields · synced May 30, 2026