McKesson

Basic Information

• Brand Name: McKesson
• Primary DI: 00612479153455
• Version / Model: 59-46R
• Company Name: MCKESSON MEDICAL-SURGICAL INC.
• Labeler DUNS: 023904428
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-24
• Public Version: 1
• Public Version Date: 2019-05-02
• Public Version Status: New
• Public Device Record Key: 5968f8af-fcd4-4703-9f99-1ed178e9f3bf

Device Description

Hot & Cold Compress 4.75 in x 6 in

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	890.5700	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	00612479153462	GS1	Case	24	In Commercial Distribution
Primary	00612479153455	GS1