DONJOY

Basic Information

• Brand Name: DONJOY
• Primary DI: 00888912003643
• Version / Model: 11-0681-9-00000
• Company Name: DJO, LLC
• Labeler DUNS: 081840873
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 5
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: 3a7e2643-0eff-4a71-ab56-449a7e6f000d

Device Description

COLD PAD,UNIV LOOP,NS,RH,XL

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
ILO	Pack, hot or cold, water circulating	Physical Medicine	890.5720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32965	Circulating-fluid localized thermal therapy system pack, reusable	A device intended to be applied to part of the body as part of a circulating-fluid localized thermal therapy system to provide localized heat and/or cold therapy for the skin and/or underlying tissues (e.g., muscle) in the treatment of musculoskeletal pain and discomfort. It typically consists of a compact envelope that is heated and/or cooled with circulating fluid (e.g., water) from the system control unit. It is intended for use in both professional and home settings. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888912003643	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			XL