Uni-Patch - Heavy Duty Cold Pack,Reusable - Cardinal Health, Inc.

Duns Number:080935429

Device Description: Heavy Duty Cold Pack,Reusable

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More Product Details

Catalog Number

MH72099

Brand Name

Uni-Patch

Version/Model Number

MH72099

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

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 Details

Product Code

IME

Product Code Name

Pack, hot or cold, reusable

Device Record Status

Public Device Record Key

7c239ad3-040b-4d47-b6ea-8a6cdd9ff6d2

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 27, 2018

Additional Identifiers

Package DI Number

20884527022448

Quantity per Package

16

Contains DI Package

10884527022441

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"CARDINAL HEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 672
2 A medical device with a moderate to high risk that requires special controls. 1692
U Unclassified 17