Hemotherm 86022
GUDID 10613031860221
Hemotherm® Dual Reservoir Cooler/Heater (115V, 50Hz)
Cincinnati Sub-Zero Products, Inc.
Cardiopulmonary bypass system heating/cooling unit Cardiopulmonary bypass system heating/cooling unit Cardiopulmonary bypass system heating/cooling unit Cardiopulmonary bypass system heating/cooling unit Cardiopulmonary bypass system heating/cooling unit Cardiopulmonary bypass system heating/cooling unit Cardiopulmonary bypass system heating/cooling unit Cardiopulmonary bypass system heating/cooling unit Cardiopulmonary bypass system heating/cooling unit Cardiopulmonary bypass system heating/cooling unit Cardiopulmonary bypass system heating/cooling unit Cardiopulmonary bypass system heating/cooling unit Cardiopulmonary bypass system heating/cooling unit Cardiopulmonary bypass system heating/cooling unit| Primary Device ID | 10613031860221 |
| NIH Device Record Key | 7ee2a50e-65ed-460e-a56c-29a038bfe6d4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hemotherm |
| Version Model Number | 400CE |
| Catalog Number | 86022 |
| Company DUNS | 004249462 |
| Company Name | Cincinnati Sub-Zero Products, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 | 8009897373 |
| csz@genthermcsz.com | |
| Phone | 8009897373 |
| csz@genthermcsz.com | |
| Phone | 8009897373 |
| csz@genthermcsz.com | |
| Phone | 8009897373 |
| csz@genthermcsz.com | |
| Phone | 8009897373 |
| csz@genthermcsz.com | |
| Phone | 8009897373 |
| csz@genthermcsz.com | |
| Phone | 8009897373 |
| csz@genthermcsz.com | |
| Phone | 8009897373 |
| csz@genthermcsz.com | |
| Phone | 8009897373 |
| csz@genthermcsz.com | |
| Phone | 8009897373 |
| csz@genthermcsz.com | |
| Phone | 8009897373 |
| csz@genthermcsz.com | |
| Phone | 8009897373 |
| csz@genthermcsz.com | |
| Phone | 8009897373 |
| csz@genthermcsz.com | |
| Phone | 8009897373 |
| csz@genthermcsz.com |
Device Dimensions
| Area/Surface Area | 484 Square inch |
| Height | 32 Inch |
| Depth | 22 Inch |
| Width | 22 Inch |
| Weight | 198 Pound |
| Area/Surface Area | 484 Square inch |
| Height | 32 Inch |
| Depth | 22 Inch |
| Width | 22 Inch |
| Weight | 198 Pound |
| Area/Surface Area | 484 Square inch |
| Height | 32 Inch |
| Depth | 22 Inch |
| Width | 22 Inch |
| Weight | 198 Pound |
| Area/Surface Area | 484 Square inch |
| Height | 32 Inch |
| Depth | 22 Inch |
| Width | 22 Inch |
| Weight | 198 Pound |
| Area/Surface Area | 484 Square inch |
| Height | 32 Inch |
| Depth | 22 Inch |
| Width | 22 Inch |
| Weight | 198 Pound |
| Area/Surface Area | 484 Square inch |
| Height | 32 Inch |
| Depth | 22 Inch |
| Width | 22 Inch |
| Weight | 198 Pound |
| Area/Surface Area | 484 Square inch |
| Height | 32 Inch |
| Depth | 22 Inch |
| Width | 22 Inch |
| Weight | 198 Pound |
| Area/Surface Area | 484 Square inch |
| Height | 32 Inch |
| Depth | 22 Inch |
| Width | 22 Inch |
| Weight | 198 Pound |
| Area/Surface Area | 484 Square inch |
| Height | 32 Inch |
| Depth | 22 Inch |
| Width | 22 Inch |
| Weight | 198 Pound |
| Area/Surface Area | 484 Square inch |
| Height | 32 Inch |
| Depth | 22 Inch |
| Width | 22 Inch |
| Weight | 198 Pound |
| Area/Surface Area | 484 Square inch |
| Height | 32 Inch |
| Depth | 22 Inch |
| Width | 22 Inch |
| Weight | 198 Pound |
| Area/Surface Area | 484 Square inch |
| Height | 32 Inch |
| Depth | 22 Inch |
| Width | 22 Inch |
| Weight | 198 Pound |
| Area/Surface Area | 484 Square inch |
| Height | 32 Inch |
| Depth | 22 Inch |
| Width | 22 Inch |
| Weight | 198 Pound |
| Area/Surface Area | 484 Square inch |
Operating and Storage Conditions
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| 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 Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10613031860221 [Primary] |
FDA Product Code
| DWC | Controller, Temperature, Cardiopulmonary Bypass |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-23 |
| Device Publish Date | 2015-10-06 |
Devices Manufactured by Cincinnati Sub-Zero Products, Inc.
| 10613031860221 - Hemotherm | 2019-12-23Hemotherm® Dual Reservoir Cooler/Heater (115V, 50Hz) |
| 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 [Hemotherm]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEMOTHERM 73324828 1262892 Live/Registered |
Cincinnati Sub-Zero Products, Inc. 1981-08-24 |
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