Catalog Number

-

Brand Name

BluFlex

Version/Model Number

BLU640CB

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 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

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

53262215-7e94-4684-953d-584333ae2223

Public Version Date

December 31, 2021

Public Version Number

3

DI Record Publish Date

July 19, 2017

Package DI Number

24719873230048

Quantity per Package

2

Contains DI Package

14719873230041

Package Discontinue Date

December 31, 2021

Package Status

Not in Commercial Distribution

Package Type

BOX