Catalog Number

21-031-001

Brand Name

InPouch® TV

Version/Model Number

1031

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K896296,K896296,K896296

Product Code

JSN

Product Code Name

Culture Media, Propagating Transport

Public Device Record Key

bc2a11ca-9c0c-4a6d-912e-95e0037a0859

Public Version Date

May 07, 2019

Public Version Number

2

DI Record Publish Date

August 20, 2018

Package DI Number

B08810317

Quantity per Package

100

Contains DI Package

B08810310

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box