Catalog Number

-

Brand Name

PRO1TEK Trauma First Aid Bleeding Control Kit-2+ Patient IFAK w/ BC

Version/Model Number

B283E2IFBOD0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OHO

Product Code Name

First Aid Kit Without Drug

Public Device Record Key

6f3eab1d-44cf-4706-8694-62c3f63f080d

Public Version Date

October 26, 2018

Public Version Number

1

DI Record Publish Date

September 25, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-