BVA100

Basic Information

• Brand Name: BVA100
• Primary DI: B641BVA100SOFTWARE60
• Version / Model: v6.0.4.
• Company Name: DAXOR CORPORATION
• Labeler DUNS: 790888833
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-03
• Public Version: 1
• Public Version Date: 2018-10-04
• Public Version Status: New
• Public Device Record Key: 7cd9c282-40c2-44d3-82ad-9f8614882666

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.

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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
JWO	Device, Blood Volume Measuring	Hematology	864.5950	2

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	B641BVA100SOFTWARE60	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K964406	000