Catalog Number

-

Brand Name

Freestyle Flex Tubing

Version/Model Number

101038234

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K191653,K191653,K191653

Product Code

GAZ

Product Code Name

Tubing, Noninvasive

Public Device Record Key

7b3c5220-47a8-493f-ab1a-f60a05991a9e

Public Version Date

October 30, 2019

Public Version Number

1

DI Record Publish Date

October 22, 2019

Package DI Number

07612367071734

Quantity per Package

126

Contains DI Package

07612367071383

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-