IFAK - Responder Bleed Kit, Custom - FARETEC, INC.

Duns Number:626802540

Device Description: Responder Bleed Kit, Custom

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More Product Details

Catalog Number

3332025

Brand Name

IFAK

Version/Model Number

Responder Bleed Kit

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

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

OHO

Product Code Name

First Aid Kit Without Drug

Device Record Status

Public Device Record Key

df6baad9-0476-45f1-b4cd-ad4cfe86e829

Public Version Date

September 08, 2020

Public Version Number

1

DI Record Publish Date

August 31, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FARETEC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 138
2 A medical device with a moderate to high risk that requires special controls. 1