Identity
- Trade Name
- McKesson FDA UDI
- Generic Name
- Haemoglobin analyser IVD, point-of-care FDA UDI
- Device Name
- Hemoglobin Cuvette Holder FDA UDI
- Model / Reference
- 900-902MCK FDA UDI
- Description
- Hemoglobin Cuvette Holder FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10612479234144 FDA UDI
- 510(k) Number
- K172173 FDA UDI
- FDA Product Code
- GKR FDA UDI
- GMDN Term
- Haemoglobin analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5620 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
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
Category: Haemoglobin analyser IVD, point-of-care
McKesson by Mckesson Medical-Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- HemoCue® Hb 201 Microcuvettes — Hemocue, Inc. · Class II
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- HemoCue® Hb 301 Microcuvettes — Hemocue, Inc. · Class II
Cleared under the same submission
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
- Mckesson Medical-Surgical Inc.
Sources (1)
- FDA UDI 21e06a77-04d8-476d-b289-cd559cdacda6 34 fields · synced May 30, 2026