AccessGUDID - DEVICE: GARYLINE (00661948011765)

GUDID

Device Identifier (DI) Information

Brand Name: GARYLINE
Version or Model: CK-CONTENTS-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Gary Plastic Packaging Corp.

Primary DI Number: 00661948011765
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001619337 *Terms of Use

Device Description: - 1 COLD PACK - 1 FOREHEAD THERMOMETER - 3 2X2 GAUZE PAD - 3 3X3 GAUZE PAD - 2 PAIRS OF GLOVES - ELASTIC BANDAGE - TAPE - 6 MOIST TOWELETTE - 1 EMERGENCY BLANKET - 6 ALCOHOL PREP PADS - 1 LG BUTTERFLY BANDAGE - 12 PLASTIC BANDAGES - 2 2X3 PLASTIC POUCHES

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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
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?
43000	First aid kit, non-medicated, reusable	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 reusable 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 91f359ee-f463-4bbc-90f1-373157e08130
Public Version Date: June 25, 2024
Public Version Number: 1
DI Record Publish Date: June 17, 2024