BVA-100 Convenience Kits - Collection of medical components used to withdraw - DAXOR CORPORATION

Duns Number:790888833

Device Description: Collection of medical components used to withdraw blood samples for use in determinations Collection of medical components used to withdraw blood samples for use in determinations of total blood and plasma volumes.

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More Product Details

Catalog Number

-

Brand Name

BVA-100 Convenience Kits

Version/Model Number

BVA-100 CONVKIT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KST

Product Code Name

System, Blood Collection, Vacuum-Assisted, Manual

Device Record Status

Public Device Record Key

15d68396-afcd-4752-8652-49abd3fe14ce

Public Version Date

October 08, 2020

Public Version Number

1

DI Record Publish Date

September 30, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DAXOR CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 2