Identity
- Trade Name
- Daxor BVA FDA UDI
- Generic Name
- Blood volume analyser IVD FDA UDI
- Device Name
- Second Generation Blood Volume Analyzer FDA UDI
- Model / Reference
- BVA-200 FDA UDI
- Description
- Second Generation Blood Volume Analyzer FDA UDI
Identifiers
- Primary DI / UDI-DI
- B641DAXBVA2 FDA UDI
- 510(k) Number
- K251087 FDA UDI
- FDA Product Code
- JWO FDA UDI
- GMDN Term
- Blood volume analyser IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5950 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 7 Pound FDA UDIHeight — 6 Inch FDA UDILength — 12 Inch FDA UDIWidth — 4 Inch FDA UDI
Category: Blood volume analyser IVD
Daxor BVA by Daxor Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood volume analyser IVD.
- BVA100 — Daxor Corporation · Class II
- BVA100 — Daxor Corporation · Class I
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
- Daxor Corporation
Sources (1)
- FDA UDI b572cf81-0e7d-433c-8f9d-121f50174116 36 fields · synced May 30, 2026