Kool Kit® Neonate 82950
GUDID 20613031829508
Thermal Regulating System
Cincinnati Sub-Zero Products, Inc.
Circulating-fluid whole-body heating/cooling system pad, single-use| Primary Device ID | 20613031829508 |
| NIH Device Record Key | 34e49287-1864-45bf-b237-d3c4ada4f27b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kool Kit® Neonate |
| Version Model Number | 950 |
| Catalog Number | 82950 |
| Company DUNS | 004249462 |
| Company Name | Cincinnati Sub-Zero Products, Inc. |
| Device Count | 5 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com | |
| Phone | 1-800-989-7373 |
| csz@genthermcsz.com |
Device Dimensions
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
| Depth | 1.63 Inch |
| Width | 11 Inch |
| Length | 14.25 Inch |
| Weight | 0.15 Pound |
Operating and Storage Conditions
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
| Storage Environment Temperature | Between -40 Degrees Celsius and 65.6 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 95 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10613031829501 [Unit of Use] |
| GS1 | 20613031829508 [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 | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-08-30 |
Devices Manufactured by Cincinnati Sub-Zero Products, Inc.
| 10613031860221 - Hemotherm | 2019-12-23 Hemotherm® Dual Reservoir Cooler/Heater (115V, 50Hz) |
| 20613031823001 - Maxi-Therm®Lite Staff Vest | 2018-06-14 Hyper-Hypothermia Blanket |
| 20613031825104 - Cold Therapy Temp-Pads® | 2018-06-11 Water Circulating Hot or Cold Pack |
| 20613031828143 - Cold Therapy Temp Pads® | 2018-05-21 Water Circulating Hot or Cold Pack |
| 20613031501374 - Cold Therapy Temp-Pads® | 2018-03-29 Water Circulating Hot or Cold Pack |
| 20613031506256 - Cold Therapy Temp-Pads® | 2018-03-29 Water Circulating Hot or Cold Pack |
| 20613031506270 - Cold Therapy Temp-Pads® | 2018-03-29 Water Circulating Hot or Cold Pack |
| 20613031506287 - Cold Therapy Temp-Pads® | 2018-03-29 Water Circulating Hot or Cold Pack |
Trademark Results [Kool Kit]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KOOL KIT 75127938 2052862 Dead/Cancelled |
Igloo Products Corp. 1996-07-01 |
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