BVA100

GUDID B641BVA100SOFTWARE60

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

DAXOR CORPORATION

Blood volume analyser IVD Blood volume analyser IVD

• Primary Device ID: B641BVA100SOFTWARE60
• NIH Device Record Key: 7cd9c282-40c2-44d3-82ad-9f8614882666
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BVA100
• Version Model Number: v6.0.4.
• Company DUNS: 790888833
• Company Name: DAXOR CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 865-425-0555
• Email: rdodgen@daxor.com
• Phone: 865-425-0555
• Email: rdodgen@daxor.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B641BVA100SOFTWARE60 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964406

FDA Product Code

• JWO: Device, Blood Volume Measuring

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-04
• Device Publish Date: 2018-09-03

On-Brand Devices [BVA100]

• B641SC25MK20: An electro-mechanical carousel instrument that provides movement and placement of blood plasma s
• B641BVA100SOFTWARE60: The BVA-100 Software v6.0.4. calculates and reports a blood volume determination based on data r