QuikClot - BCK, QuikClot Bleeding Control Kit, CAT, Pro - Z-MEDICA, LLC

Duns Number:079190073

Device Description: BCK, QuikClot Bleeding Control Kit, CAT, Pro

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More Product Details

Catalog Number

0539

Brand Name

QuikClot

Version/Model Number

0539

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

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

-

Product Code Details

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

1cc2fb12-e841-42d0-8387-4a424dc1b54b

Public Version Date

February 21, 2022

Public Version Number

5

DI Record Publish Date

February 10, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"Z-MEDICA, LLC" Characteristics
Device Class Device Class Description No of Devices
U Unclassified 27