Gelli-Roll® Pediatric Size 82198
GUDID 10613031821987
Water Circulating Hot or Cold Pack
Gentherm Medical, LLC
Circulating-fluid whole-body heating/cooling system pad, reusable| Primary Device ID | 10613031821987 |
| NIH Device Record Key | 94ca1c39-d0db-468a-bbec-5a46cdc8b8e7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gelli-Roll® Pediatric Size |
| Version Model Number | 194P |
| Catalog Number | 82198 |
| Company DUNS | 004249462 |
| Company Name | Gentherm Medical, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com |
Device Dimensions
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
| Height | 0.5 Inch |
| Width | 23.25 Inch |
| Length | 30.75 Inch |
| Weight | 25 Pound |
Operating and Storage Conditions
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 107 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 42 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10613031821987 [Primary] |
FDA Product Code
| ILO | Pack, Hot Or Cold, Water Circulating |
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 | 2016-09-19 |
Devices Manufactured by Gentherm Medical, LLC
| 10613031871074 - Blanketrol | 2024-07-03 Patient warming and cooling device |
| 10613031873078 - Blanketrol | 2024-05-21 Patient Heating and Cooling Device |
| 10613031838732 - Maxi-Therm Lite | 2024-05-21 Thermal Regulation Pad |
| 10613031838749 - Maxi-Therm Lite | 2024-05-21 Thermal Regulation Pad |
| 10613031838763 - Maxi-Therm Lite | 2024-05-21 Thermal Regulation Pad |
| 10613031839005 - Kool-Kit | 2024-05-21 Thermal Regulation Pad |
| 10613031839203 - Kool-Kit | 2024-05-21 Thermal Regulation Pad |
| 10613031839302 - Kool-Kit | 2024-05-21 Thermal Regulation Pad |
Trademark Results [Gelli-Roll]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GELLI-ROLL 77165035 3406370 Live/Registered |
GENTHERM MEDICAL, LLC 2007-04-25 |
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