BVA-100 Convenience Kit 9ml

GUDID B641CONVKIT1009

Collection of medical components used to withdraw blood samples for use in determinations of total blood and plasma volumes - 9ml Vacutainer

DAXOR CORPORATION

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• Primary Device ID: B641CONVKIT1009
• NIH Device Record Key: ff233c41-98ac-4cf9-a86a-4f365f51ac36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BVA-100 Convenience Kit 9ml
• Version Model Number: BVA-100 CONVKIT
• Company DUNS: 790888833
• Company Name: DAXOR CORPORATION
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B641CONVKIT1009 [Primary]

FDA Product Code

• KST: System, Blood Collection, Vacuum-Assisted, Manual

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-01
• Device Publish Date: 2023-07-24

Devices Manufactured by DAXOR CORPORATION

• B641CONVKIT1009 - BVA-100 Convenience Kit 9ml: 2023-08-01Collection of medical components used to withdraw blood samples for use in determinations of total blood and plasma volumes - 9ml Vacutainer
• B641CONVKIT1009 - BVA-100 Convenience Kit 9ml: 2023-08-01 Collection of medical components used to withdraw blood samples for use in determinations of total blood and plasma volumes - 9m
• B641BVA200 - BVA200CONVKIT: 2023-07-20 New convenience kit to support a new clinical process and Blood volume analyzer
• B641CONVKIT1000 - BVA-100 Convenience Kits: 2020-10-08 Collection of medical components used to withdraw blood samples for use in determinations of total blood and plasma volumes.
• B641MAX10055 - MAX-100: 2020-10-08 Sterile Syringe delivery device used to deliver (inject) Volumex (I-131 HSA) for use in determination of total blood and plasma
• B641BVA100SOFTWARE60 - BVA100: 2018-10-04 The BVA-100 Software v6.0.4. calculates and reports a blood volume determination based on data retrieved from sampling points ta
• B641MAX1004 - MAX-100: 2018-09-21 Sterile syringe delivery device used to deliver (inject) Volumex (Iodinated I-131Allbumin injection) for use in determinations o
• B641SC25MK20 - BVA100: 2018-09-03 An electro-mechanical carousel instrument that provides movement and placement of blood plasma specimens to ensure the proper co