Catalog Number

-

Brand Name

Biowy Freezing Bag

Version/Model Number

FB500

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

BK170150,BK170150

Product Code

LPZ

Product Code Name

Container, Frozen Donor Tissue Storage

Public Device Record Key

ee080f07-b7e8-4e38-a9ec-1cce891e2955

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

May 24, 2021

Package DI Number

00851739007248

Quantity per Package

24

Contains DI Package

00851739007026

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box