FDA.reportPublic FDA data

Relief Pak 12 pack heating Unit

Primary DI
08809520550246
Brand
Relief Pak 12 pack heating Unit
Company
KARIS Co.,Ltd
Model
11-1985
Device description
It is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.
Published
2023-01-25
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
08809520550246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809520550246088095205502468809520550246

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.

Contacts#

Phone, Email table
PhoneEmail
+827088941972karis@karis.co.kr
+821087093990karis@karis.co.kr

Regulatory Flags#

DUNS number
689514726
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
08809520550369Moist Hot-Pack UnitKRS-4P-A1A312023-02-23
08809520550376Moist Hot-Pack UnitKRS-6P-A1A322023-02-23
08809520550383Moist Hot-Pack UnitKRS-8P-A1A322023-02-23
08809520550390Moist Hot-Pack UnitKRS-12P-A1A322023-02-23
08809520550406Moist Hot-Pack UnitKRS-24P-A1A322023-02-23
08809520550413Moist Hot-Pack UnitKRS-4P-A1D312023-02-23
08809520550420Moist Hot-Pack UnitKRS-4P-A1D322023-02-23
08809520550437Moist Hot-Pack UnitKRS-6P-A1D322023-02-23
08809520550444Moist Hot-Pack UnitKRS-8P-A1D322023-02-23
08809520550451Moist Hot-Pack Unit KRS-12P-A1D322023-02-23
08809520550468Moist Hot-Pack UnitKRS-24P-A1D322023-02-23
08809520550475Moist Hot-Pack UnitKRS-4P-A2D322023-02-23
08809520550482Moist Hot-Pack UnitKRS-6P-A2D322023-02-23
08809520550499Moist Hot-Pack UnitKRS-8P-A2D322023-02-23
08809520550505Moist Hot-Pack UnitKRS-12P-A2D322023-02-23
08809520550512Moist Hot-Pack Unit KRS-24P-A2D322023-02-23
08809520550529Relief Pak 4 pack heating Unit stationary11-19812023-02-23
08809520550536Relief Pak 4 pack heating Unit stationary11-19802023-02-23
08809520550543Relief Pak 6 pack heating Unit stationary11-19822023-02-23
08809520550550Relief Pak 8 pack heating Unit mobile11-19842023-02-23

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