WarmTouch

Basic Information

• Brand Name: WarmTouch
• Primary DI: 10884521084599
• Version / Model: 502-2000
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-03
• Public Version: 6
• Public Version Date: 2022-11-09
• Public Version Status: Update
• Public Device Record Key: 51c8ddac-0cfd-4476-a68e-bf5285567a21
• Distribution End Date: 2019-11-01

Device Description

Patient Warming System, Patient Warming Unit Hose Assembly (5200/5800)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• 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
DWJ	System, thermal regulating	Cardiovascular	870.5900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36954	Circulating-air whole-body heating system control unit	A mains electricity (AC-powered) device intended to be used as part of a circulating-air whole-body heating system to filter, and control/regulate the temperature and flow of room air through a connected patient-applied pad (not included), for heating a patient’s whole-body (i.e., elevate core body temperature to achieve normothermia). The device includes a filter, an air heater and air pump. It is intended to be used by a healthcare professional in a clinical setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521084599	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K123083	000