FDA.report

HydraTherm

Primary DI
00850958007015
Brand
HydraTherm
Company
Compass Richmar, LLC
Model
HT-R12-DW220
Device description
HydraTherm Heater-Deluxe, Divider 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
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IRQUnit, Heating, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
IRQUnit, Heating, PoweredPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850958007015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850958007015008509580070158509580070150850958007015

GMDN Terms

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

Contacts

PhoneEmail
1-888-549-4945customerservice@richmarweb.com
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags

DUNS number
080930531
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10850689007336STICK-E-PADS203-6742016-11-18
10850689007343STICK-E-PADS203-6752016-11-18
10850689007350STICK-E-PADS203-6732016-11-18
10850689007367STICK-E-PADS203-6722016-11-18
10850689007374STICK-E-PADS203-6802016-11-18
10850689007381STICK-E-PADS203-6812016-11-18
10850689007398STICK-E-PADS203-6762016-11-18
10850689007404STICK-E-PADS203-6772016-11-18
10850689007428ValueStim202-6752016-11-18
10850689007442ValueStim202-6762016-11-18
10850689007466Adhesive Electrodes202-4542016-11-18
10850689007473Adhesive Electrodes202-4552016-11-18

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07898966442933IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIRQ2025-02-25
07898966442964IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIRQ2025-02-25
00092237626009HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-05-14
00092237626016HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-05-14
00092237625545HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625552HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625569HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625576HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625583HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625590HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625606HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625613HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625620HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625637HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625644HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625651HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625668HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625675HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-06
00092237625460HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-05
00092237625477HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-05
00092237625484HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-05
00092237625491HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-05
00092237625507HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-05
00092237625514HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-05
00092237625521HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-05
00092237625538HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-05
00092237625439HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-03-01
00092237625354HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-02-29
00092237625361HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-02-29
00092237625378HydraThermCOMPASS HEALTH BRANDS CORP.IRQ2024-02-29