FDA.reportPublic FDA data

warmUP

Primary DI
00851137008007
Brand
warmUP
Company
Avacore Technologies, Inc.
Model
WU-20
Catalog number
WU-20
Device description
Warm UP Control Unit
Published
2024-08-22
Public version status
New
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
K040911000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040911000VITALHEATDynatherm Medical, Inc.2004-06-22DWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851137008007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851137008007008511370080078511370080070851137008007

GMDN Terms#

Term, Definition table
TermDefinition
External circulating-fluid core temperature regulation system control unit, heating/coolingAn electrically-powered device intended to be used as part of an external circulating-fluid core temperature regulation system to control/regulate the temperature and flow of fluid through a connected patient-applied pad (not included), to both elevate and alternatively lower a patient’s core body temperature. The device includes a heater and refrigeration unit, a pump, and typically a water reservoir; it may also be intended for patient temperature monitoring and typically includes alarms for cases of water temperatures beyond pre-set limits. It is intended to be used by a healthcare professional in a clinical setting (e.g., to achieve normothermia).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-282-2673info@avacore.com

Regulatory Flags#

DUNS number
036950975
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851137008014warmUPWU-200LWU-200L2025-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06950456323373NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30
06950456323380NAHangzhou Tappa Medical Technology Co., Ltd.DWJ2026-09-30