FDA.reportPublic FDA data

ice o therm pro

Primary DI
00683601000060
Brand
ice o therm pro
Company
Saringer Life Science Technologies Inc
Model
contrast
Device description
the ice o therm pro is used for applying controlled localized contrast ( hot and cold ) to a specific part of the body.
Published
2017-09-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00683601000060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00683601000060006836010000606836010000600683601000060

GMDN Terms#

Term, Definition table
TermDefinition
Electric pad localized-body heating systemAn assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is normally available [non-prescription] over-the-counter (OTC) for use in the home.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
905 640 0060christine@saringer.com

Regulatory Flags#

DUNS number
243385601
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00683601000077ice o therm procold2017-12-29
00683601000022venowavevw5-10vw5-10 case of 2 units2016-09-21
00683601000053venowavevw5-6m2016-09-21

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