Identity
- Trade Name
- HemoScreen FDA UDI
- Generic Name
- Capillary blood collection tube IVD, K2EDTA FDA UDI
- Device Name
- A disposable unit used for the collection of the blood sample FDA UDI
- Model / Reference
- CBC Sampler FDA UDI
- Description
- A disposable unit used for the collection of the blood sample FDA UDI
Identifiers
- Catalog Number
- BC-FA-00201 FDA UDI
- Primary DI / UDI-DI
- 07290016991048 FDA UDI
- 510(k) Number
- K180020 FDA UDI
- FDA Product Code
- GKZ FDA UDI
- GMDN Term
- Capillary blood collection tube IVD, K2EDTA FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5220 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
HemoScreen by Pixcell Medical Technologies, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K180020 also covers:
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
- Pixcell Medical Technologies, Ltd.
Sources (1)
- FDA UDI 95c45829-a81b-4810-909b-9e41479e0f82 38 fields · synced May 30, 2026