AccessGUDID - DEVICE: Quality Choice (00635515998537)

GUDID

Device Identifier (DI) Information

Brand Name: Quality Choice
Version or Model: 635515998537
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CHAIN DRUG MARKETING ASSOCIATION, INC.

Primary DI Number: 00635515998537
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 011920774 *Terms of Use

Device Description: All-purpose, First Aid Kit, 140 items, Including One Carrying Case: 34- Sheer Antibacterial* Bandages 5/8 in. x 2 1/4 in. (1.5 cm x 5.7 cm), 30- Sheer Antibacterial* Bandages 3/4 in. x 3 in. (1.9 cm x 7.6 cm), 15- Fabric Antibacterial* Bandages 5/8 in. x 2 1/4 in. (1.5 cm x 5.7 cm), 14- Sheer Antibacterial* Bandages 7/8 in. (2.2 cm), 12- Butterfly Closures 1 3/4 in. x 3/8 in. (4.4 cm x .95 cm), 10- Fabric Antibacterial* Bandages 3/4 in. x 3 in. (1.9 cm x 7.6 cm), 5- Fabric Antibacterial* Bandages 1 in. x 3 in. (2.5 cm x 7.6 cm), 2- Sheer Antibacterial* Bandages 2 1/4 in. x 3 in. (5.7 cm x 7.6 cm), 1- Instant Cold Pack 5 in. x 6 in. (12.7 cm x 15.3 cm), 1- Paper Tape Roll 1/2 in. x 5 yd. (1.2 cm x 4.5 m), 4- Hand Cleansing Wipes 4 3/4 in. x 7 3/4 in. (12 cm x 19.6 cm), 2- Triple Antibiotic Ointment 1/32 oz. (0.9 g), 6- Gauze Pads, 2 in. x 2 in. (5 cm x 5 cm) 2- Non-Stick** Pads, 2 in. x 3 in. (5 cm x 7.6 cm), 1- Carrying Case, 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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	Yes
Combination Product:	Yes
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: ac4b5aa4-3252-41b6-965d-5385ca3d6e74
Public Version Date: January 30, 2023
Public Version Number: 2
DI Record Publish Date: August 09, 2021