Identity
- Trade Name
- HemoCue® 801 Connect FDA UDI
- Generic Name
- Laboratory instrument/analyser application software IVD FDA UDI
- Device Name
- HemoCue® 801 Connect FDA UDI
- Model / Reference
- 139168 FDA UDI
- Description
- HemoCue® 801 Connect FDA UDI
Identifiers
- Catalog Number
- 139168 FDA UDI
- Primary DI / UDI-DI
- 07311091391681 FDA UDI
- FDA Product Code
- JQP FDA UDI
- GMDN Term
- Laboratory instrument/analyser application software IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2100 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
HemoCue® 801 Connect by Hemocue, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hemocue, Inc.
Sources (1)
- FDA UDI 02ad6600-8af0-4a6b-ab7e-00af877062f8 35 fields · synced Jun 7, 2026