FDA.reportPublic FDA data

Controller

Primary DI
00851446007012
Brand
Controller
Company
VITA HEAT MEDICAL
Model
2002
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.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWJSystem, Thermal Regulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWJSystem, Thermal RegulatingCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132454000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132454000VITAHEAT PATIENT WARMING SYSTEMVitaheat Medical, LLC2013-10-04DWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851446007012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851446007012008514460070128514460070120851446007012

GMDN Terms#

Term, Definition table
TermDefinition
Electric pad whole-body heating system control unitA mains electricity (AC-powered) device intended to be used as part of an electrical whole-body heating system to regulate and monitor the temperature of an electrically-heated, patient-applied pad (not included), for heating a patient’s whole body (i.e., elevate core body temperature to achieve normothermia). It is intended to be used by a healthcare professional in a clinical setting.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.850.8350pfarmakis@vitaheatmedical.com

Regulatory Flags#

DUNS number
021249224
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851446007104VitaHEAT UB3 Patient Warming System - Battery Power7003-A2016-09-23
00851446007128VitaHEAT UB3 Patient Warming System - AC Power7003-B2016-09-23
00851446007142VitaHEAT UB3 Patient Warming System- Battery and AC Power7003-C2016-09-23
00851446007005Patient Warming Mattress40032016-09-23
00851446007067AC Power Adapter 100026-PA2016-09-23
00851446007098AC Power Adapter Subassembly Kit1000026-PA-SA2016-09-23
00851446007043Battery Charger3001-C2016-09-23
00851446007081Battery Power Subassembly3001262016-09-23
00851446007036Battery1000262016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0078755104171240675 Hot Pink Pad XL - with Arm ProtectorsXODUS MEDICAL, INC.DWJ2026-10-19
06951013004124KoZee Warming BlanketJiangmen Dacheng Medical Equipment Co., Ltd.DWJ2026-10-15
06950456323090NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323106NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323113NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323120NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323137NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323144NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323151NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323168NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323175NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323182NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323199NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323205NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323212NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323229NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323236NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323243NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323250NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323267NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323274NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323281NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323298NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323304NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323311NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323328NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323335NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323342NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323359NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323366NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30