VitaHEAT UB3 Patient Warming System - Battery Power

GUDID 00851446007104

The Model 7003-A, VitaHEAT UB3 Patient Warming System - Battery Power includes a Model 4003 Patient Warming Mattress, a Model 2002 Controller, QTY 2 Model 100026 Batteries, and a Model 3001-C Battery Charger.

VITA HEAT MEDICAL

Electric pad whole-body heating system
Primary Device ID00851446007104
NIH Device Record Keyae38fcc5-0942-453a-9261-7324c5625acc
Commercial Distribution StatusIn Commercial Distribution
Brand NameVitaHEAT UB3 Patient Warming System - Battery Power
Version Model Number7003-A
Company DUNS021249224
Company NameVITA HEAT MEDICAL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800.850.8350
Emailpfarmakis@vitaheatmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100851446007104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWJSystem, Thermal Regulating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

Devices Manufactured by VITA HEAT MEDICAL

00851446007043 - Battery Charger2020-02-06 The Model 3001-C Battery Charger provides charging power to a Model 100026 Batteries.
00851446007081 - Battery Power Subassembly2020-02-06 The Model 300126 Battery Power Subassembly is Model 3001-C Battery Charger and QTY 2 Model 100026 Batteries as a subassembly, bu
00851446007005 - Patient Warming Mattress2018-07-06 The Model 4003 Patient Warming Mattress is an electrical patient warming mattress that is connected to a Model 2002 Controller a
00851446007012 - Controller2018-07-06 The Model 2002 Controller regulates the temperature of and the power to the Model 4003 Patient Warming Mattress. It is powered
00851446007036 - Battery2018-07-06 The Model 100026 Battery provides power to the Model 2002 Controller. The Battery is charged by the 3001-C Battery Charger.
00851446007067 - AC Power Adapter 2018-07-06 The Model 100026-PA AC Power Adapter Provides power to the Model 2002 Controller.
00851446007098 - AC Power Adapter Subassembly Kit2018-07-06 The Model 100026-PA-SA AC Power Adapter Subassembly is a Model 100026-PA AC Power Adapter as a subassembly. This includes Model
00851446007104 - VitaHEAT UB3 Patient Warming System - Battery Power2018-07-06The Model 7003-A, VitaHEAT UB3 Patient Warming System - Battery Power includes a Model 4003 Patient Warming Mattress, a Model 2002 Controller, QTY 2 Model 100026 Batteries, and a Model 3001-C Battery Charger.
00851446007104 - VitaHEAT UB3 Patient Warming System - Battery Power2018-07-06 The Model 7003-A, VitaHEAT UB3 Patient Warming System - Battery Power includes a Model 4003 Patient Warming Mattress, a Model 20
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