Controller

Basic Information

• Brand Name: Controller
• Primary DI: 00851446007012
• Version / Model: 2002
• Company Name: VITA HEAT MEDICAL
• Labeler DUNS: 021249224
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: 28b0f308-e42c-4705-b536-022463d94f00

Device Description

The Model 2002 Controller regulates the temperature of and the power to the Model 4003 Patient Warming Mattress. It is powered by Model 100026-PA AC Power Adapter or Model 100026 Battery. The Controller monitors current, zone power, the temperature sensors, and detects faults in the mattress or system.

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
36955	External electric-heating core temperature regulation system control unit	An electrically-powered device intended to be used as part of an external electric-heating core temperature regulation system to regulate and monitor the temperature of an electrically-heated, patient-applied pad (not included), for elevation of a patient’s core body temperature (i.e., to achieve normothermia). 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	00851446007012	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K132454	000