AccessGUDID - DEVICE: BE SMART GET PREPARED (00020424021368)

GUDID

Device Identifier (DI) Information

Brand Name: BE SMART GET PREPARED
Version or Model: 10OUT02136; 10OUT02136RECOM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: X0044NVI6F
Company Name: TOTAL RESOURCES INTERNATIONAL INC.

Primary DI Number: 00020424021368
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790160535 *Terms of Use

Device Description: CHILL OUT, HEAT RELIEF First Aid Kit, 21 pcs – By Be Smart Get Prepared - (10) Electrolyte Tablets 1 pack; (2) Instant Cold Compresses 5 in x 6 in [12.70 cm x 15.24 cm]; (2) Instant Cool Patches 2 in x 4.80 in [5.08 cm x 12.19 cm]; (2) Cohesive Wrap 1 in x 90 in (2 yd 1 1/2 ft) [2.54 cm x 2.29 m]; (2) Forehead Thermometers; (3) Emergency Waters 4.22 fl oz [124.80 ml]

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
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?
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: 1045d409-6cb5-4ce9-849f-1fc0a49ca98a
Public Version Date: March 26, 2024
Public Version Number: 2
DI Record Publish Date: February 01, 2024