FDA UDI
In Commercial Distribution
🇺🇸 United States
BVA100
DI: B641SC25MK20
·
Model: SC25 MK2
·
DAXOR CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BVA100
- Primary DI
- B641SC25MK20
- Version / Model
- SC25 MK2
- Company Name
- DAXOR CORPORATION
- Labeler DUNS
- 790888833
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-01
- Public Version
- 1
- Public Version Date
- 2018-09-03
- Public Version Status
- New
- Public Device Record Key
- e2484550-3ad8-4662-a4a2-f3c37cd19748
Device Description
An electro-mechanical carousel instrument that provides movement and placement of blood plasma specimens to ensure the proper counting sequence for a blood volume test.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47534 | Blood volume analyser IVD | A mains electricity (AC-powered) instrument intended to be used for the quantitative in vitro measurement of a patient's circulating blood volume, plasma volume and/or red cell volume. Measurements are typically performed on blood specimens collected at specified intervals following the introduction of a radioactive tracer (e.g., iodine isotope 131) through an intravenous line, and the dispersion or rate of dilution of the tracer solution is used to determine blood volume by comparing sequential samples to a calculated ideal blood volume based on height, weight, gender and deviation from the patient's ideal weight. It operates with automation of some procedural steps. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B641SC25MK20 | HIBCC |
Customer Contacts
- Phone
- 865-425-0555
- [email protected]