FDA.report

Whitehall Thermalators

Primary DI
00645724000211
Brand
Whitehall Thermalators
Company
Whitehall Manufacturing Co
Model
ET-4-S
Catalog number
ET-4-S
Device description
220 V, 4-Pack Capacity Moist Heat Unit
Published
2018-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
00645724000211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00645724000211006457240002116457240002110645724000211

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
(800) 782-7706info@whitehallmfg.com

Regulatory Flags

DUNS number
008312423
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00645724004516Whitehall ThermalatorT12MLTEG26T12MLTEG262019-05-01
00645724004523ThermasplintSP1502EG26SP-1502-EG262019-05-01
00645724004530Whitehall ThermalatorsT4SEG26T-4-S-EG262019-05-01
00645724004547Hydrotherapy WhirlpoolE15MEG26E-15-M-EG262019-05-01
00645724000037Whitehall ThermalatorsET-12-M-FLATBTMET12MFLATBTM2019-02-11
00645724000044Whitehall ThermalatorsET-12-M-SPCORDET12MSPCORD2019-02-11
00645724000051Whitehall ThermalatorsET-4-S-SPCORDET4SSPCORD2019-02-11
00645724000068Whitehall ThermalatorsET-6-S-SPCORDET6SSPCORD2019-02-11
00645724000075Whitehall TheralatorsET-8-M-SPCORDET8MSPCORD2019-02-11
00645724003540ThermasplintSM-1501B-CORD2SM1501BCORD22019-02-11
00645724003557ThermasplintSM-1502B-CORD1SM1502BCORD12019-02-11
00645724003564ThermasplintSM-1502B-CORD2SM1502BCORD22019-02-11
00645724003571ThermasplintSM-1502B-CORD3SM1502BCORD32019-02-11
00645724003588ThermasplintSM-1502B-CORD4SM1502BCORD42019-02-11
00645724003595ThermasplintSM-1502B-CORD5SM1502BCORD52019-02-11
00645724003601ThermasplintSM-1502B-CORD7SM1502BCORD72019-02-11
00645724003618ThermasplintSP-1501B-CORD1SP1501BCORD12019-02-11
00645724003625ThermasplintSP-1501B-CORD2SP1501BCORD22019-02-11
00645724003632ThermasplintSP-1501B-CORD3SP1501BCORD32019-02-11
00645724003649ThermasplintSP-1501B-CORD4SP1501BCORD42019-02-11

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