Norm-O-Temp® 86154
GUDID 10613031861549
Total Body Hyperthermia System
Gentherm Medical, LLC
Circulating-fluid whole-body heating/cooling system control unit| Primary Device ID | 10613031861549 |
| NIH Device Record Key | f02e9ab2-9e30-40e6-a2c3-d2eddeb892c1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Norm-O-Temp® |
| Version Model Number | 111Z |
| Catalog Number | 86154 |
| 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 |
| 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
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
| Weight | 15.2 Kilogram |
| Weight | 33.5 Pound |
| Height | 46.9 Centimeter |
| Height | 18.5 Inch |
| Depth | 38.1 Centimeter |
| Depth | 15 Inch |
| Width | 22.9 Centimeter |
| Width | 9 Inch |
Operating and Storage Conditions
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| 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 |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10613031861549 [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 | 2016-08-31 |
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 [Norm-O-Temp]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NORM-O-TEMP 72374289 0943322 Live/Registered |
CINCINNATI SUB-ZERO PRODUCTS, INC. 1970-10-26 |
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