Plastipad® Pediatric Size 82194

GUDID 10613031821949

Water Circulating Hot or Cold Pack

Gentherm Medical, LLC

Circulating-fluid whole-body heating/cooling system pad, reusable
Primary Device ID10613031821949
NIH Device Record Key47faf7f8-e91d-4ef8-8000-0bbb5842cca5
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlastipad® Pediatric Size
Version Model Number194
Catalog Number82194
Company DUNS004249462
Company NameGentherm Medical, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com

Device Dimensions

Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound
Width22.25 Inch
Length29.75 Inch
Weight2 Pound

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 150 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 65.6 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 107 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 42 Degrees Celsius
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS110613031821949 [Primary]

FDA Product Code

ILOPack, Hot Or Cold, Water Circulating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-09-23
Device Publish Date2016-09-19

On-Brand Devices [Plastipad® Pediatric Size]

10613031821949Water Circulating Hot or Cold Pack
10613031501117Water Circulating Hot or Cold Pack

Trademark Results [Plastipad]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PLASTIPAD
PLASTIPAD
73199749 1242682 Live/Registered
Cincinnati Sub-Zero Products, Inc.
1979-01-12

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