Catalog Number

-

Brand Name

Bioseal

Version/Model Number

17323/20

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

-

Product Code

GAZ

Product Code Name

TUBING, NONINVASIVE

Public Device Record Key

47f6e118-b404-42c1-b3df-b7797c733129

Public Version Date

January 30, 2020

Public Version Number

1

DI Record Publish Date

January 22, 2020

Package DI Number

10630094173235

Quantity per Package

20

Contains DI Package

00630094173238

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case