EMT Kit - EMT KITSWAT-T Tourniquet 1 eaRolled Gauze - Safeguard US Operating, LLC

Duns Number:118492643

Device Description: EMT KITSWAT-T Tourniquet 1 eaRolled Gauze 1 eaDuct Tape 1 ea

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More Product Details

Catalog Number

88-112

Brand Name

EMT Kit

Version/Model Number

01

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"

Yes

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

OHO

Product Code Name

First Aid Kit Without Drug

Device Record Status

Public Device Record Key

ba863c7e-381f-472e-9479-87c06987b56a

Public Version Date

April 12, 2022

Public Version Number

2

DI Record Publish Date

July 19, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SAFEGUARD US OPERATING, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 217
2 A medical device with a moderate to high risk that requires special controls. 48