COLUMBUS CITY SCHOOLS STB KIT - (1) TMT (Tactical Mechanical Tourniquet)(1) - Safeguard US Operating, LLC

Duns Number:118492643

Device Description: (1) TMT (Tactical Mechanical Tourniquet)(1) SWAT-T Orange(3) Compressed Gauze (2) Pair Vin (1) TMT (Tactical Mechanical Tourniquet)(1) SWAT-T Orange(3) Compressed Gauze (2) Pair Vinyl Glove (1) CPR Microshield (1) Trauma Shear 5.5 (1) Permanent Marker(1) Emergency Instructions

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More Product Details

Catalog Number

SH-CCS-SM

Brand Name

COLUMBUS CITY SCHOOLS STB 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"

-

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 Details

Product Code

OHO

Product Code Name

First Aid Kit Without Drug

Device Record Status

Public Device Record Key

3aba254b-b4cd-421c-a36b-50f843c67747

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 23, 2022

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