AccessGUDID - DEVICE: LEADER (00096295125559)

GUDID

Device Identifier (DI) Information

Brand Name: LEADER
Version or Model: 4935516
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4935516
Company Name: Cardinal Health 110, Inc.

Primary DI Number: 00096295125559
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 063997360 *Terms of Use

Device Description: First Aid Kit; First Aid Essentials; Pack and Go Convenience; 12 Items and 1 Carrying Case; 6 Fabric Antibacterial Bandages with First Aid Antiseptic; Active Ingredient: Benzalkonium Chloride 0.1 percent; 2 Hand Cleansing Wipes; 4 Sterile Pads; For External Use Only

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:	No
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: Yes
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: 1e1937e7-055e-42b5-aac4-34345b91167b
Public Version Date: July 02, 2021
Public Version Number: 2
DI Record Publish Date: April 18, 2019