EverFlo 1020005
GUDID 00606959032545
EverFlo International, Non-OPI, 220V L.A.BRAZIL
Respironics, Inc.
Stationary oxygen concentrator| Primary Device ID | 00606959032545 |
| NIH Device Record Key | 5a17211b-dfac-4c10-892c-40c40fcb7ac1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EverFlo |
| Version Model Number | 00 |
| Catalog Number | 1020005 |
| 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 | 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
Operating and Storage Conditions
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
| Storage Environment Temperature | Between -34 Degrees Celsius and 71 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Fahrenheit and 160 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00606959032545 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K061261
FDA Product Code
| CAW | Generator, oxygen, portable |
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 | 2018-07-06 |
| Device Publish Date | 2017-01-17 |
On-Brand Devices [EverFlo]
| 00606959022041 | EverFlo Domestic OPI 120V - US, Canada |
| 00606959020436 | EverFlo, OPI, 230V, UltraFill - Australia |
| 00606959014954 | EverFlo Domestic NON-OPI 120V - US CANADA |
| 00606959001077 | EverFlo International, OPI, 230V - Australia |
| 00606959032798 | EverFlo Stationary Oxygen Concentrator with Ultrafill Oxygen Filling Station with OPI (Oxygen Pe |
| 00606959032781 | EverFlo, OPI, 230V, 60Hz - Saudi Arabia |
| 00606959032774 | EverFlo International, OPI, 230V - China |
| 00606959032767 | EVERFLO,120V,BRAZIL |
| 00606959032750 | EVERFLO,120V,OPI,BRAZIL |
| 00606959032736 | EverFlo, OPI, CEE 7-7, IKK, 230V, UltraFill |
| 00606959032729 | EverFlo, CEE 7-7, OPI, 230V, UltraFill - EUR |
| 00606959032705 | EverFlo, OPI, 230V, UltraFill - UK |
| 00606959032699 | EverFlo Quiet, Domestic, 120V, UltraFill |
| 00606959032682 | EverFlo Quiet, Domestic, OPI, 120V, UltraFill |
| 00606959032675 | EverFlo Domestic, OPI, 120V, UltraFill |
| 00606959032668 | EverFlo Domestic, 120V, UltraFill |
| 00606959032651 | EverFlo International, OPI, 230V, Switzerland |
| 00606959032644 | EverFlo International, OPI, 230V, Hong Kong |
| 00606959032637 | EverFlo Q, Domestic, Non-OPI, 120V - US, Canada |
| 00606959032620 | EverFlo Q, Domestic, OPI, 120V - US, Canada |
| 00606959032613 | EVERFLO,OPI 230V60HZ,KOREA |
| 00606959032606 | EverFlo International, OPI, 230V - Argentina |
| 00606959032590 | EverFlo International, OPI, 230V - Italy Chile |
| 00606959032583 | EverFlo International, OPI, 230V - South Africa |
| 00606959032576 | EverFlo International, OPI, 230V - UK, Ireland |
| 00606959032569 | EverFlo International, OPI, 230V, IKK |
| 00606959032552 | EverFlo International, OPI, 230V - EU |
| 00606959032545 | EverFlo International, Non-OPI, 220V L.A.BRAZIL |
| 00606959032538 | EverFlo International, OPI, 220V - L.A.Brazil |
| 00606959032521 | EverFlow International, Non-OPI, 120V, L.A. |
| 00606959032514 | EverFlo International, OPI, 120V, L.A. |
| 00606959047921 | EVERFLO Q INTL,OPI,230V,CHINA |
Trademark Results [EverFlo]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EVERFLO 98309721 not registered Live/Pending |
Everflow (Singapore) Pte. Ltd. 2023-12-12 |
 EVERFLO 78895523 not registered Dead/Abandoned |
RIC Investments, LLC 2006-05-30 |
 EVERFLO 77957888 3881654 Live/Registered |
Valley Industries LLP 2010-03-12 |
 EVERFLO 72230220 0822856 Dead/Expired |
AIRSTREAM, INC. 1965-10-15 |
 EVERFLO 72055885 0677538 Live/Registered |
J. C. SIVAK 1958-07-23 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.