FDA.report

Lotion/Gel Warmer

Primary DI
00853904006124
Brand
Lotion/Gel Warmer
Company
Compass Richmar, LLC
Model
203-764
Device description
White 3 Bottle Warmer (220V)
Published
2016-09-01
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
00853904006124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00853904006124008539040061248539040061240853904006124

GMDN Terms

TermDefinition
Gel warmerA portable, mains electricity (AC-powered) device intended to be used to prewarm gels (e.g., ultrasonic coupling gels, vaginal exploratory gels) prior to patient application. It is typically a tabletop device that includes a recess or a well for placement of a gel container, a heating element, a thermostat, and operating controls.

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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10853904006060BodyMed Iontophoresis Electrode KitLarge, Box of 122016-05-02
10853904006077BodyMed Iontophoresis Electrode KitButterfly, Box of 122016-05-02
10850958007159GelShotGSA2CH12016-11-23
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10850689007329STICK-E-PADS203-6792016-11-18
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