| 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 |