FDA.reportPublic FDA data

Cold Therapy Temp-Pads®

Primary DI
20613031506294
Brand
Cold Therapy Temp-Pads®
Company
Gentherm Medical, LLC
Model
1215-US
Catalog number
50629
Device description
Water Circulating Hot or Cold Pack
Published
2017-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILOPack, Hot Or Cold, Water Circulating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILOPack, Hot Or Cold, Water CirculatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20613031506294PrimaryGS10
10613031506297Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2061303150629420613031506294
1061303150629710613031506297

GMDN Terms#

Term, Definition table
TermDefinition
Circulating-fluid thermal therapy system pack, single-useA device intended to be applied to part of the body as part of a circulating-fluid thermal therapy system to provide localized heat and/or cold therapy for the skin and/or underlying tissues (e.g., muscle) in the treatment of musculoskeletal pain and discomfort. It typically consists of a compact envelope that is heated and/or cooled with circulating fluid (e.g., water) from the system control unit. It is intended for use in both professional and home settings. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Inch
Weight0.4Pound
Width11Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Handling Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit
Storage Environment Humidity20 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature-40 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-989-7373csz@genthermcsz.com

Regulatory Flags#

DUNS number
004249462
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10613031871074Blanketrol233871072024-06-25
20613031838739Maxi-Therm Lite 873-USME873-USME2024-05-13
20613031838746Maxi-Therm Lite 874-USME874-USME2024-05-13
20613031838760Maxi-Therm Lite 876-USME876-USME2024-05-13
20613031839002Kool-Kit 900-USME900-USME2024-05-13
20613031839200Kool-Kit 920-USME920-USME2024-05-13
20613031839309Kool-Kit 930-USME930-USME2024-05-13
20613031839507Kool-Kit 950-USME950-USME2024-05-13
10613031873078Blanketrol2332332024-05-13
10613031838732Maxi-Therm Lite 873-USME873-USME2024-05-13
10613031838749Maxi-Therm Lite 874-USME874-USME2024-05-13
10613031838763Maxi-Therm Lite 876-USME876-USME2024-05-13
10613031839005Kool-Kit 900-USME900-USME2024-05-13
10613031839203Kool-Kit 920-USME920-USME2024-05-13
10613031839302Kool-Kit 930-USME930-USME2024-05-13
10613031839500Kool-Kit 950-USME950-USME2024-05-13
20613031812432FilteredFlo® PACU Adult Blanket243812432022-08-22
20613031812449FilteredFlo® Pediatric Blanket244812442022-08-22
20613031832430FilteredFlo® PACU Adult Blanket243832432017-08-30
20613031832461FilteredFlo® Neonate/Pediatric Blanket246832462022-08-22

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