Mojo First Responder Bag - Intermediate Case of 5 - Case of 5 for Mojo First Responder-Intermediate - Safeguard US Operating, LLC

Duns Number:118492643

Device Description: Case of 5 for Mojo First Responder-Intermediate Your Mojo Medical Bag is equipped with MAR Case of 5 for Mojo First Responder-Intermediate Your Mojo Medical Bag is equipped with MARCH Medical Gear featuringsimple treatment icons andcolor-coding below:MASSIVE HEMORRAHAGEAIRWAYRESPIRATIONCIRCULATIONHEAD & HYPOTHERMIA

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More Product Details

Catalog Number

83-303-05

Brand Name

Mojo First Responder Bag - Intermediate Case of 5

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)

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

LRR

Product Code Name

First Aid Kit With Drug

Device Record Status

Public Device Record Key

555790bb-b725-4667-bb8b-88330604dd30

Public Version Date

April 12, 2022

Public Version Number

2

DI Record Publish Date

July 30, 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