AccessGUDID - DEVICE: Honeywell Safety Products USA, Inc. (00821812025032)

GUDID

Device Identifier (DI) Information

Brand Name: Honeywell Safety Products USA, Inc.
Version or Model: 019700-0001L
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: North Safety de Mexicali, S. de R. L. de C.V.

Primary DI Number: 00821812025032
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 812503712 *Terms of Use

Device Description: First Aid kit containing Medical Devices Class I: Gauze Pads, Tweezer Plastics, Gauze clean-wrap, Scissor Bandage, Nitrile Gloves, Plastic Bands, Tape Adhesive, Triangular Bandage, Eye Pads, Woven Fingengertip Bandage, Cold Pack.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44047	First aid kit, non-medicated, single-use	A convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHO	First Aid Kit Without Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 82 and 89 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ff5d01d4-12b2-4e16-bc50-0df3d514246c
Public Version Date: October 05, 2020
Public Version Number: 1
DI Record Publish Date: September 26, 2020