Penguin Cold Therapy® 86243
GUDID 10613031862430
Cold Therapy Device
Gentherm Medical, LLC
Circulating-fluid thermal therapy system control unit Circulating-fluid thermal therapy system control unit Circulating-fluid thermal therapy system control unit Circulating-fluid thermal therapy system control unit Circulating-fluid thermal therapy system control unit Circulating-fluid thermal therapy system control unit Circulating-fluid thermal therapy system control unit Circulating-fluid thermal therapy system control unit Circulating-fluid thermal therapy system control unit Circulating-fluid thermal therapy system control unit Circulating-fluid thermal therapy system control unit Circulating-fluid thermal therapy system control unit Circulating-fluid thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit| Primary Device ID | 10613031862430 |
| NIH Device Record Key | 46e22463-9a5f-423c-a288-22d8da61727a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Penguin Cold Therapy® |
| Version Model Number | 707 KST |
| Catalog Number | 86243 |
| 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 | true |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
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 | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
| Height | 28.6 Centimeter |
| Height | 11.25 Inch |
| Width | 24.8 Centimeter |
| Width | 9.75 Inch |
| Length | 40.6 Centimeter |
| Length | 16 Inch |
| Weight | 3 Kilogram |
| Weight | 6.6 Pound |
Operating and Storage Conditions
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10613031862430 [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 | 2016-08-29 |
On-Brand Devices [Penguin Cold Therapy®]
| 10613031862454 | Cold Therapy Device |
| 10613031862430 | Cold Therapy Device |
Trademark Results [Penguin Cold Therapy]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PENGUIN COLD THERAPY 76635545 3298521 Live/Registered |
GENTHERM MEDICAL, LLC 2005-04-08 |
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