FDA.reportPublic FDA data

Daxor BVA

Primary DI
B641DAXBVA2
Brand
Daxor BVA
Company
DAXOR CORPORATION
Model
BVA-200
Device description
Second Generation Blood Volume Analyzer
Published
2025-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K251087000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251087000Blood Volume Analyzer (200)Daxor Corporation2025-08-04JWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B641DAXBVA2PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height6Inch
Length12Inch
Weight7Pound
Width4Inch

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
790888833
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
B641BVA100SOFTWARE60BVA100v6.0.4.2018-09-03
B641MAX1004MAX-100MAX-100 Syringe2018-08-21
B641SC25MK20BVA100SC25 MK22018-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B641BVA100SOFTWARE60BVA100DAXOR CORPORATIONJWO2018-09-03