Honeywell Safety Products USA, Inc. - First Aid Kit containing Medical Devices class I - North Safety de Mexicali, S. de R. L. de C.V.

Duns Number:812503712

Device Description: First Aid Kit containing Medical Devices class I and Drugs OTC: Knuckle Band, Triple Antib First Aid Kit containing Medical Devices class I and Drugs OTC: Knuckle Band, Triple Antibiotic, First Aid Burn Cream, Triangular Bandage, Gauze Pads, Adhesive Tape, Forceps, Scissors, Gauze compress, Cold Pack, Buffered Eye wash, Bandage compress, Adhesive Bandage, PVP Iodine wipes, Nitrile Gloves, Nox A Sting Wipes.

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More Product Details

Catalog Number

-

Brand Name

Honeywell Safety Products USA, Inc.

Version/Model Number

019710-0006L

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

LRR

Product Code Name

First Aid Kit With Drug

Device Record Status

Public Device Record Key

9a39d4fc-cc3d-4281-bd36-5dcbf664431a

Public Version Date

October 05, 2020

Public Version Number

1

DI Record Publish Date

September 26, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NORTH SAFETY DE MEXICALI, S. DE R. L. DE C.V." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 1