FilteredFlo® Lower Body OR Blanket 83442
GUDID 20613031834427
WarmAir 135 patient warming system.
Cincinnati Sub-Zero Products, Inc.
Circulating-air whole-body heating/cooling system pad, single-use, non-sterile| Primary Device ID | 20613031834427 |
| NIH Device Record Key | ff5db064-2a0c-4978-927b-1a664709121c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FilteredFlo® Lower Body OR Blanket |
| Version Model Number | 442 |
| Catalog Number | 83442 |
| Company DUNS | 004249462 |
| Company Name | Cincinnati Sub-Zero Products, Inc. |
| Device Count | 10 |
| 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 | true |
| 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 | 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 | |
| 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 | |
| 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
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 Inch |
| Width | 40 Inch |
| Length | 53 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| 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 |
| Handling Environment Temperature | Between 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit |
| Handling Environment Temperature | Between 16 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10613031834420 [Unit of Use] |
| GS1 | 20613031834427 [Primary] |
| GS1 | 30613031834424 [Package] Package: Case [40 Units] In Commercial Distribution |
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 | 2016-08-26 |
On-Brand Devices [FilteredFlo® Lower Body OR Blanket]
| 20613031834427 | WarmAir 135 patient warming system. |
| 20613031824602 | WarmAir 135 patient warming system. |
Trademark Results [FilteredFlo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FILTEREDFLO 74373492 1889211 Live/Registered |
GENTHERM MEDICAL, LLC 1993-03-29 |
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