Primary Device ID | B641BVA200 |
NIH Device Record Key | 507fe0b7-6421-462d-a6d3-3d825ddebadb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | BVA200CONVKIT |
Version Model Number | BVA200CONVKIT |
Catalog Number | BVA200CK |
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 |
Phone | 865-425-0555 |
jadkins@daxor.com | |
Phone | 865-425-0555 |
jadkins@daxor.com | |
Phone | 865-425-0555 |
jadkins@daxor.com | |
Phone | 865-425-0555 |
jadkins@daxor.com | |
Phone | 865-425-0555 |
jadkins@daxor.com | |
Phone | 865-425-0555 |
jadkins@daxor.com | |
Phone | 865-425-0555 |
jadkins@daxor.com | |
Phone | 865-425-0555 |
jadkins@daxor.com | |
Phone | 865-425-0555 |
jadkins@daxor.com | |
Phone | 865-425-0555 |
jadkins@daxor.com | |
Phone | 865-425-0555 |
jadkins@daxor.com | |
Phone | 865-425-0555 |
jadkins@daxor.com | |
Phone | 865-425-0555 |
jadkins@daxor.com | |
Phone | 865-425-0555 |
jadkins@daxor.com | |
Phone | 865-425-0555 |
jadkins@daxor.com | |
Phone | 865-425-0555 |
jadkins@daxor.com | |
Phone | 865-425-0555 |
jadkins@daxor.com | |
Phone | 865-425-0555 |
jadkins@daxor.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B641BVA200 [Primary] |
HIBCC | B641CONVKIT2000 [Package] Package: Bag [1 Units] In Commercial Distribution |
KST | System, Blood Collection, Vacuum-Assisted, Manual |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-07-20 |
Device Publish Date | 2023-07-12 |
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 | 2023-07-20New convenience kit to support a new clinical process and Blood volume analyzer |
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 |