Catalog Number

836075

Brand Name

Vacuette

Version/Model Number

836075

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 03, 2021

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JPH

Product Code Name

TEST, ERYTHROCYTE SEDIMENTATION RATE

Public Device Record Key

1b4b3258-9fa8-412c-aeef-8f2428c11b80

Public Version Date

December 06, 2021

Public Version Number

3

DI Record Publish Date

September 30, 2020

Package DI Number

39120017578179

Quantity per Package

8

Contains DI Package

29120017578172

Package Discontinue Date

December 02, 2021

Package Status

Not in Commercial Distribution

Package Type

-