FDA.reportPublic FDA data

Whitehall Thermalators

Primary DI
00645724000037
Brand
Whitehall Thermalators
Company
Whitehall Manufacturing Co
Model
ET-12-M-FLATBTM
Catalog number
ET12MFLATBTM
Device description
THERMALATOR,12 PACK,EURO W/FLAT BTM
Published
2019-02-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00645724000037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00645724000037006457240000376457240000370645724000037

GMDN Terms#

Term, Definition table
TermDefinition
Cold therapy pack chilling unitA mains electricity (AC-powered) device used to chill the contents of a reusable cold therapy pack or hot/cold therapy pack to temperatures appropriate to apply cold 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 chilling and handling of the many cold therapy packs, and chilling elements (e.g., integral coils) that create temperatures of around minus 17? Celsius. 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
(800) 782-7706info@whitehallmfg.com

Regulatory Flags#

DUNS number
008312423
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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
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
00645724003656ThermasplintSP-1501B-CORD5SP1501BCORD52019-02-11

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