FDA.reportPublic FDA data

HydraTherm

Primary DI
00850958007046
Brand
HydraTherm
Company
Drive Devilbiss Healthcare
Model
HT-R12-SRW220
Device description
HydraTherm Heater - Standard, Traditional Rack System, 12x HydraHeat Packs (220V)
Published
2016-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IRQUnit, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRQUnit, Heating, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850958007046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850958007046008509580070468509580070460850958007046

GMDN Terms#

Term, Definition table
TermDefinition
Hot therapy pack heating unitA mains electricity (AC-powered) device used to heat the contents of a reusable hot therapy pack to temperatures appropriate to apply heat therapy to the human body. This device, also known as a hydrocollator, typically consists of a stainless steel container, shelves, trays, or drawers that facilitate the heating and handling of the many hot therapy packs, and heating elements that heat the packs to a specified temperature so that the they are conditioned for reuse when needed. It is typically used in accident and emergency (A&E) rooms, rehabilitation facilities and for physiotherapy treatments.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-549-4945customerservice@richmarweb.com
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
867673159
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10092237600105Roscoe MedicalEP4070WCD2016-10-18
90002360125501AccuReliefACRL-55002016-10-12
00009223761699Reliable MedicalEF2020BC2-TU2018-06-13
00009223761941EswallowESW-90502016-12-31
00023601005144CAREX HEALTH BRANDSFGA51400 00002022-12-20
00023601005151CAREX HEALTH BRANDSFGA51500 BLUE2022-12-20
00023601005168CAREX HEALTH BRANDSFGA51600 GRN2022-12-20
00023601005175CAREX HEALTH BRANDSFGA51700 BRNZ2022-12-20
00023601005182CAREX HEALTH BRANDSFGA51800 GRAY2022-12-20
00023601007117CAREX HEALTH BRANDSFGA71100 00002023-03-15
00023601007179CAREX HEALTH BRANDSFGA71700 00002023-03-15
00023601007186CAREX HEALTH BRANDSFGA71800 00002023-03-15
00023601007193CAREX HEALTH BRANDSFGA71900 00002023-03-15
00023601012210Carex Health BrandsFGA22100 00002022-12-09
00023601012227CAREX HEALTH BRANDSFGA22200 00002022-12-12
00023601012234CAREX HEALTH BRANDSFGA22300 00002022-12-12
00023601012302CAREX HEALTH BRANDSFGA23000 00002022-12-12
00023601012319CAREX HEALTH BRANDSFGA23177 00002022-12-12
00023601012333CAREX HEALTH BRANDSFGA23300 00002022-12-12
00023601013330CAREX HEALTH BRANDSFGA33300 00002022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898966442933IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIRQ2025-02-25
07898966442964IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIRQ2025-02-25
00092237626009HydraThermDrive Devilbiss HealthcareIRQ2024-05-14
00092237626016HydraThermDrive Devilbiss HealthcareIRQ2024-05-14
00092237625545HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625552HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625569HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625576HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625583HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625590HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625606HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625613HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625620HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625637HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625644HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625651HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625668HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625675HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625460HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625477HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625484HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625491HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625507HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625514HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625521HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625538HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625439HydraThermDrive Devilbiss HealthcareIRQ2024-03-01
00092237625354HydraThermDrive Devilbiss HealthcareIRQ2024-02-29
00092237625361HydraThermDrive Devilbiss HealthcareIRQ2024-02-29
00092237625378HydraThermDrive Devilbiss HealthcareIRQ2024-02-29