NightBalance L2EU01UK
GUDID 30606959054616
NightBalance Sleep Position Trainer System, UK
Respironics, Inc.
Behavioural therapy electrical stimulation system| Primary Device ID | 30606959054616 |
| NIH Device Record Key | 1366bc4c-8db5-4934-937e-a4c7afbae9b1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NightBalance |
| Version Model Number | 00 |
| Catalog Number | L2EU01UK |
| 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 | true |
| Manufacturing Date | true |
| 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
| Phone | +1(724)744-2500 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)744-2500 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM |
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00606959054615 [Primary] |
| GS1 | 30606959054616 [Package] Contains: 00606959054615 Package: Multipack [30 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180608
FDA Product Code
| MYB | Pillow, cervical (for mild sleep apnea) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-23 |
| Device Publish Date | 2020-12-15 |
On-Brand Devices [NightBalance]
| 00606959058743 | Philips NightBalance - Replacement Chest Strap |
| 30606959059598 | Philips NightBalance, Canada |
| 30606959059581 | Philips NightBalance, Iberia |
| 30606959057518 | Philips NightBalance, Denmark |
| 30606959054630 | NightBalance Sleep Position Trainer System, Germany |
| 30606959054616 | NightBalance Sleep Position Trainer System, UK |
| 00606959054639 | NightBalance Sleep Position Trainer System, Germany |
Trademark Results [NightBalance]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NIGHTBALANCE 79197328 5197882 Live/Registered |
NightBalance B.V. 2016-07-01 |
 NIGHTBALANCE 79195525 5211411 Live/Registered |
NightBalance B.V. 2016-09-26 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.