ComfortGel 1081833
GUDID 00606959021082
Respironics, Inc.
CPAP/BPAP face mask, reusable| Primary Device ID | 00606959021082 |
| NIH Device Record Key | a78e2b01-8112-493a-8283-e9d34f5b7107 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ComfortGel |
| Version Model Number | 00 |
| Catalog Number | 1081833 |
| Company DUNS | 080728314 |
| Company Name | Respironics, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| 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
Operating and Storage Conditions
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00606959021082 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K101129
FDA Product Code
| CBK | VENTILATOR, CONTINUOUS, FACILITY USE |
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 | 2018-11-12 |
| Device Publish Date | 2015-11-06 |
On-Brand Devices [ComfortGel]
| 00606959022270 | 00 |
| 00606959022256 | 00 |
| 00606959022249 | 00 |
| 00606959022232 | 00 |
| 00606959022225 | 00 |
| 00606959022218 | 00 |
| 00606959022201 | 00 |
| 00606959022195 | 00 |
| 00606959022164 | 00 |
| 00606959022157 | 00 |
| 00606959022140 | Nasal Mask |
| 00606959022133 | 00 |
| 00606959021082 | 00 |
| 00606959021075 | 00 |
| 00606959021068 | 00 |
| 00606959021051 | 00 |
| 00606959021044 | 00 |
| 00606959021037 | 00 |
| 00606959021020 | 00 |
| 00606959020832 | 00 |
| 00606959020825 | 00 |
| 00606959020818 | 00 |
| 00606959015401 | 00 |
| 00606959015388 | 00 |
| 00606959015371 | 00 |
| 00606959013889 | 00 |
| 00606959007062 | Full Face Mask |
| 00606959007055 | 00 |
| 00606959007048 | 00 |
| 00606959007031 | 00 |
| 00606959006560 | 00 |
| 00606959006553 | 00 |
| 00606959006546 | 00 |
| 00606959006539 | 00 |
| 00606959004337 | 00 |
| 00606959004320 | 00 |
| 00606959004313 | 00 |
| 00606959004306 | 00 |
| 00606959004290 | 00 |
| 00606959004283 | 00 |
| 00606959004276 | 00 |
| 00606959004269 | 00 |
| 00606959001602 | 00 |
| 00606959001596 | 00 |
| 00606959001589 | 00 |
| 00606959001572 | Comfort Gel Blue Nasal Mask with headgear, L, International |
Trademark Results [ComfortGel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COMFORTGEL 90673803 not registered Live/Pending |
Keeco, LLC 2021-04-27 |
 COMFORTGEL 85547190 4296463 Live/Registered |
Corona Clipper, Inc. 2012-02-20 |
 COMFORTGEL 78200616 2841802 Live/Registered |
AMEDA, INC. 2003-01-07 |
 COMFORTGEL 75726548 2488596 Dead/Cancelled |
SADDLEMAN, INC. 1999-06-10 |
 COMFORTGEL 75711040 2432257 Dead/Cancelled |
SADDLEMAN, INC. 1999-05-19 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.