Catalog Number

836077

Brand Name

Vacuette

Version/Model Number

836077

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)

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

9ec5dfcb-1bed-4ea5-996c-927e08634812

Public Version Date

October 08, 2020

Public Version Number

1

DI Record Publish Date

September 30, 2020

Package DI Number

39120017578186

Quantity per Package

8

Contains DI Package

29120017578189

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-