Blanketrol® lll 86107

GUDID 10613031861075

Thermal Regulating System

Gentherm Medical, LLC

Circulating-fluid whole-body heating/cooling system control unit Circulating-fluid whole-body heating/cooling system control unit Circulating-fluid whole-body heating/cooling system control unit Circulating-fluid whole-body heating/cooling system control unit Circulating-fluid whole-body heating/cooling system control unit Circulating-fluid whole-body heating/cooling system control unit Circulating-fluid whole-body heating/cooling system control unit Circulating-fluid whole-body heating/cooling system control unit Circulating-fluid whole-body heating/cooling system control unit Circulating-fluid whole-body heating/cooling system control unit Circulating-fluid whole-body heating/cooling system control unit Circulating-fluid whole-body heating/cooling system control unit Circulating-fluid whole-body heating/cooling system control unit External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling

Primary Device ID	10613031861075
NIH Device Record Key	7fd2503c-984f-4587-ae00-2445c24c61dc
Commercial Distribution Status	In Commercial Distribution
Brand Name	Blanketrol® lll
Version Model Number	233
Catalog Number	86107
Company DUNS	004249462
Company Name	Gentherm Medical, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch
Weight	59.5 Kilogram
Weight	131 Pound
Height	95.3 Centimeter
Depth	43.2 Centimeter
Width	43.2 Centimeter
Height	37.5 Inch
Depth	17 Inch
Width	17 Inch

Operating and Storage Conditions

Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Humidity	Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Temperature	Between -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10613031861075 [Primary]

FDA Product Code

DWJ	System, Thermal Regulating

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2021-09-23
Device Publish Date	2016-08-30

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10613031842432 - FilteredFlo® PACU Adult Blanket	2022-08-30 Thermal Regulating System
10613031842449 - FilteredFlo® Pediatric Blanket	2022-08-30 Thermal Regulating System
10613031863864 - WarmAir® 135	2021-11-24 Convective Warming System
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Trademark Results [Blanketrol]

Mark Image Registration \| Serial	Company Trademark Application Date
BLANKETROL 73092040 1068469 Live/Registered	CINCINNATI SUB-ZERO PRODUCTS, INC. 1976-06-30