SIMPLYGO IT1069058
GUDID 00606959048812
SIMPLYGO,INTERNATIONAL, IT
Respironics, Inc.
Portable oxygen concentrator Portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator| Primary Device ID | 00606959048812 |
| NIH Device Record Key | a562d7e4-b0e0-4e76-85d8-66ec9419c7f6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SIMPLYGO |
| Version Model Number | 00 |
| Catalog Number | IT1069058 |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(724)744-2500 |
| RESPIRONICS.SERVICE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| RESPIRONICS.SERVICE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| RESPIRONICS.SERVICE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| RESPIRONICS.SERVICE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| RESPIRONICS.SERVICE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| RESPIRONICS.SERVICE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| RESPIRONICS.SERVICE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| RESPIRONICS.SERVICE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| RESPIRONICS.SERVICE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| RESPIRONICS.SERVICE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| RESPIRONICS.SERVICE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| RESPIRONICS.SERVICE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| RESPIRONICS.SERVICE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| RESPIRONICS.SERVICE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| RESPIRONICS.SERVICE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| RESPIRONICS.SERVICE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| RESPIRONICS.SERVICE@PHILIPS.COM |
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 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 | 00606959048812 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K111885
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 | 2017-08-14 |
On-Brand Devices [SIMPLYGO]
| 00606959048812 | SIMPLYGO,INTERNATIONAL, IT |
| 00606959028852 | SimplyGo, Saudi Arabia |
| 00606959058453 | SimplyGo Mini, Standard Battery, France |
Trademark Results [SIMPLYGO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIMPLYGO 97681749 not registered Live/Pending |
Social Media, LLC 2022-11-17 |
 SIMPLYGO 86402500 4965419 Live/Registered |
SimplyShe, Inc. 2014-09-22 |
 SIMPLYGO 79114857 4378118 Live/Registered |
Koninklijke Philips N.V. 2012-06-01 |
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