LEADER

Basic Information

• Brand Name: LEADER
• Primary DI: 00096295137347
• Version / Model: 5513205
• Catalog Number: 5513205
• Company Name: Cardinal Health 110, Inc.
• Labeler DUNS: 063997360
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2019-10-21
• Public Version: 2
• Public Version Date: 2021-07-02
• Public Version Status: Update
• Public Device Record Key: f85e0806-b835-4cbd-b273-3a7bf0f41c04

Device Description

Instant Cold Pack Twin

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IMD	PACK, HOT OR COLD, DISPOSABLE	Physical Medicine	890.5710	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40555	Hot/cold therapy pack, single-use	A non-sterile device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel, peat) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50096295137342	GS1	CASE	6	In Commercial Distribution
Primary	00096295137347	GS1
Unit of Use	10096295137344	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	6	Inch
Width	8	Inch