NightBalance L2EU01IB
GUDID 30606959059581
Philips NightBalance, Iberia
Respironics, Inc.
Behavioural therapy electrical stimulation system Behavioural therapy electrical stimulation system Behavioural therapy electrical stimulation system Behavioural therapy electrical stimulation system Behavioural therapy electrical stimulation system Behavioural therapy electrical stimulation system Behavioural therapy electrical stimulation system Behavioural therapy electrical stimulation system Behavioural therapy electrical stimulation system Behavioural therapy electrical stimulation system Behavioural therapy electrical stimulation system Behavioural therapy electrical stimulation system Behavioural therapy electrical stimulation system Behavioural therapy electrical stimulation system| Primary Device ID | 30606959059581 |
| NIH Device Record Key | 8a2d87ca-3e4f-4d13-a4f9-b5e05ca7b544 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NightBalance |
| Version Model Number | 00 |
| Catalog Number | L2EU01IB |
| 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)387-4000 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)387-4000 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)387-4000 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)387-4000 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)387-4000 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)387-4000 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)387-4000 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)387-4000 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)387-4000 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)387-4000 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)387-4000 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)387-4000 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)387-4000 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM | |
| Phone | +1(724)387-4000 |
| SUPPORT.NIGHTBALANCE@PHILIPS.COM |
Operating and Storage Conditions
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00606959059580 [Primary] |
| GS1 | 30606959059581 [Package] Contains: 00606959059580 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 | 2020-10-01 |
| Device Publish Date | 2020-09-23 |
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 |
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 |
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