Catalog Number

-

Brand Name

HCS

Version/Model Number

HCS1108HC

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"

Yes

For Single-Use

Yes

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

-

Product Code

KYR

Product Code Name

Bag, Ice

Public Device Record Key

53aa32da-2f28-4eb7-a182-ad4cf0fee8c2

Public Version Date

February 08, 2021

Public Version Number

1

DI Record Publish Date

January 29, 2021

Package DI Number

10849027004946

Quantity per Package

2

Contains DI Package

00849027004949

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case