EverFlo 1020001
GUDID 00606959022041
EverFlo Domestic OPI 120V - US, Canada
Respironics, Inc.
Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator| Primary Device ID | 00606959022041 |
| NIH Device Record Key | 9d52d213-3b98-4265-805a-b47b35e34a29 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EverFlo |
| Version Model Number | 00 |
| Catalog Number | 1020001 |
| 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 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 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00606959022041 [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 | 2016-09-23 |
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 |
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