Catalog Number

222401

Brand Name

BIOPHEN™ V-L Plasma Calibrator

Version/Model Number

222401

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K083729

Product Code

JIT

Product Code Name

Calibrator, Secondary

Public Device Record Key

e0f75900-2215-4b0c-b904-dc9b7caf61ae

Public Version Date

August 21, 2020

Public Version Number

4

DI Record Publish Date

August 25, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-