AccessGUDID - DEVICE: BE SMART GET PREPARED (00020424150037)

GUDID

Device Identifier (DI) Information

Brand Name: BE SMART GET PREPARED
Version or Model: 10COM15003
Commercial Distribution Status: In Commercial Distribution
Catalog Number: X00IN3K7C5; X0044NVFQ3
Company Name: TOTAL RESOURCES INTERNATIONAL INC.

Primary DI Number: 00020424150037
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790160535 *Terms of Use

Device Description: ALL PURPOSE First Aid, 200 Pieces by Be Smart Get Prepared - (15) Alcohol Prep Pads; (15) Antiseptic Wipes; (3) Antibiotic Ointments 0.03 oz [0.90 g]; (3) Burn Creams 0.03 oz [0.90 g]; (3) Sting Relief Wipes; (1) Instant Cold Compress 5 in x 6 in [12.70 cm x 15.24 cm]; (40) Sheer Bandages 3/4 in x 3 in [1.91 cm x 7.62 cm]; (25) Sheer Bandages 5/8 in x 2 1/4 in [1.59 cm x 5.72 cm]; (20) Butterfly Closures; (15) Sheer Dual Spot Bandages 7/8 in DIA [2.22 cm DIA]; (14) Assorted Blister Pads 1 pack; (8) Sterile Gauze Pads 2 in x 2 in/4 ply [5.08 cm x 5.08 cm]; (4) Sterile Gauze Pads 4 in x 4 in/4 ply [10.16 cm x 10.16 cm]; (3) Insect Repellents 0.03 oz [0.90 g]; (1) Triangular Bandage w/ Safety Pins 40 in (1yd 4 in) x 40 in (1 yd 4 in) x 56 in (1 yd 1 ft 8 in) [1.02 m x 1.02 m x 1.42 m]; (1) Sterile Trauma Pad 5 in x 9 in [12.70 cm x 22.86 cm]; (1) Gauze Roll 2 in x 147.60 in (4 yd 3.60 in) [5.08 cm x 3.75 m]; (1) Sheer Bandage 2 in x 4 in [5.08 cm x 10.16 cm]; (10) Cotton Tip Applicators; (5) Safety Pins; (4) Examination Gloves 2 pairs; (4) Wood Splints; (1) Tweezers 3 in [7.62 cm]; (1) Scissors 4 1/2 in [11.43 cm]; (1) Paper Tape 1/2 in x 90 in (2 yd 1 1/2 ft) [1.27 cm x 2.29 cm]; (1) First Aid Guide

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?
44039	First aid kit, medicated	A convenient collection of equipment, materials and pharmaceuticals intended to be used in an emergency for the rapid, initial treatment of an injury. It is typically used by emergency medical services (EMS), hospitals, institutions, schools, and other public settings. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRR	First Aid Kit With 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: b051bd04-b11c-48b5-9520-807c11debbe8
Public Version Date: March 26, 2024
Public Version Number: 2
DI Record Publish Date: February 29, 2024