Identity
- Trade Name
- BVA100 FDA UDI
- Generic Name
- Blood volume analyser IVD FDA UDI
- Device Name
- The BVA-100 Software v6.0.4. calculates and reports a blood volume determination based on data retrieved from sampling points taken at timed intervals. The software also determines the patient's ideal blood volume which is derived from the patient's height, weight, and gender. The software compares the computed blood volume against the ideal value to indicate a surplus or deficit in blood volume percentages. FDA UDI
- Model / Reference
- v6.0.4. FDA UDI
- Description
- The BVA-100 Software v6.0.4. calculates and reports a blood volume determination based on data retrieved from sampling points taken at timed intervals. The software also determines the patient's ideal blood volume which is derived from the patient's height, weight, and gender. The software compares the computed blood volume against the ideal value to indicate a surplus or deficit in blood volume percentages. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B641BVA100SOFTWARE60 FDA UDI
- 510(k) Number
- K964406 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood volume analyser IVD
Bva100 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 I
- Daxor BVA — Daxor 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
- Daxor Corporation
Sources (1)
- FDA UDI 7cd9c282-40c2-44d3-82ad-9f8614882666 35 fields · synced May 31, 2026