Catalog Number

8-5110

Brand Name

QC Bagset

Version/Model Number

70176

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

BK070006,BK070006,BK070006

Product Code

OAO

Product Code Name

Cord Blood Processing System And Storage Container

Public Device Record Key

7cb61118-52a3-4fbb-ac1b-ea365af6ad77

Public Version Date

January 12, 2021

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

20886368000326

Quantity per Package

4

Contains DI Package

10886368000329

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pallet