FDA.reportPublic FDA data

BVA100

Primary DI
B641BVA100SOFTWARE60
Brand
BVA100
Company
DAXOR CORPORATION
Model
v6.0.4.
Device 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.
Published
2018-09-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWODevice, Blood Volume Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWODevice, Blood Volume MeasuringHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K964406000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964406000AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZERDaxor Corporation1997-09-25JWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B641BVA100SOFTWARE60PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blood volume analyser IVDA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
865-425-0555rdodgen@daxor.com

Regulatory Flags#

DUNS number
790888833
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B641DAXBVA2Daxor BVABVA-2002025-09-05
B641MAX1000MAX-100MAX-100 Syringe2018-08-21
B641MAX10055MAX-100MAX-100 Syringe2020-09-30
B641CONVKIT1009BVA-100 Convenience Kit 9mlBVA-100 CONVKIT2023-07-24
B641BVA200BVA200CONVKITBVA200CONVKITBVA200CK2023-07-12
B641CONVKIT1000BVA-100 Convenience KitsBVA-100 CONVKIT2020-09-30
B641MAX1004MAX-100MAX-100 Syringe2018-08-21
B641SC25MK20BVA100SC25 MK22018-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B641DAXBVA2Daxor BVADAXOR CORPORATIONJWO2025-09-05