FDA.reportPublic FDA data

NightBalance

Primary DI
00606959059597
Brand
NightBalance
Company
Respironics, Inc.
Model
00
Catalog number
L2US01CA
Device description
Philips NightBalance, Canada
Published
2020-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MYBPillow, cervical (for mild sleep apnea)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYBPillow, Cervical (For Mild Sleep Apnea)Dental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180608000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180608000Lunoa SystemNightbalance BV2018-06-05MYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30606959059598PackageGS130In Commercial Distribution
00606959059597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3060695905959830606959059598
00606959059597006069590595976069590595970606959059597

GMDN Terms#

Term, Definition table
TermDefinition
Behavioural therapy electrical stimulation systemAn assembly of devices designed to apply harmless but unpleasant electrical impulses to a patient (e.g., in the arm or leg) to modify undesirable behavioural characteristics (e.g., self injurious behaviour). It is typically used for aversion therapy sessions conducted by a therapist and/or in clinical programs at home. Some assemblies include an annoying sound stimulus for sound or sound/electric aversion conditioning. The system is often used in the treatment of obsessive/compulsive behaviour and drug abuse.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius45 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit113 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(724)387-4000SUPPORT.NIGHTBALANCE@PHILIPS.COM

Regulatory Flags#

DUNS number
080728314
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00606959055735Sleepware G3 Sleepware G3 2026-01-22
00606959060586Care OrchestratorCare Orchestrator2026-01-22
00606959424852DreamStation BiPAP autoSVDreamStation BiPAP autoSV w/Humid w/H tube w/Cell,AUX900T15C2017-02-01
00606959424944DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humidifier w/Cell,AUX1131H15C2017-02-10
00606959424951DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Cell, AUAUX1131S15C2017-02-10
00606959424968DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humd w/H Tube w/CeAUX1131T15C2017-02-10
00606959424975DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humidifier w/WiFi,AUX1131H15W2017-02-10
00606959424982DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/WiFi, AUAUX1131S15W2017-02-10
00606959424999DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 AE w/Humid w/H Tube w/WAUX1131T15W2017-02-10
00606959425378DreamStation01CNX1130T172019-12-29
00606959425385DreamStation01CNX1131H172019-12-29
00606959425392DreamStation01CNX1131S172019-12-29
00606959425408DreamStation01CNX1131T172019-11-20
00606959425484DreamStation BiPAP autoSVDreamStation BiPAP autoSV w/Humid w/H Tube, w/CellCAX900T12C2017-02-01
00606959425491DreamStation BiPAP autoSVDreamStation BiPAP autoSV w/Humid w/H Tube, w/WiFiCAX900T12W2017-02-01
00606959425538DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Humidifier w/Cell, CACAX1130H12C2017-02-10
00606959425545DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Cell, CACAX1130S12C2017-02-10
00606959425552DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Humid w/H Tube w/CellCAX1130T12C2017-02-10
00606959425569DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/Humidifier w/WiFi, CACAX1130H12W2017-02-10
00606959425576DreamStation BiPAP AVAPSDreamStation BiPAP AVAPS30 w/WiFi, CACAX1130S12W2017-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850063034319Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-12-08
00850063034326Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-12-08
00850063034333Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-12-08
00850063034357Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-12-08
00850063034340Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-11-14
70850015266194Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-10-27
00850063034302Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-08-21
00850063034272Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-07-21
00850063034289Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-07-21
00850063034265Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-05-22
10850015266192Night ShiftADVANCED BRAIN MONITORING, INC.MYB2024-03-14
00850015266492Night ShiftADVANCED BRAIN MONITORING, INC.MYB2022-03-29
00850015266508Night ShiftADVANCED BRAIN MONITORING, INC.MYB2022-03-29
00850015266515Night ShiftADVANCED BRAIN MONITORING, INC.MYB2022-03-29
00850015266195Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
00850015266218Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
00850015266232Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
20850015266199Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
30850015266196Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
40850015266193Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
50850015266190Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
60850015266197Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
80850015266191Night ShiftADVANCED BRAIN MONITORING, INC.MYB2021-04-27
00606959054615NightBalanceRespironics, Inc.MYB2020-12-15
00606959054639NightBalanceRespironics, Inc.MYB2020-12-15
30606959054616NightBalanceRespironics, Inc.MYB2020-12-15
30606959054630NightBalanceRespironics, Inc.MYB2020-12-15
00850015266072Night ShiftADVANCED BRAIN MONITORING, INC.MYB2020-09-30
00850015266089Night ShiftADVANCED BRAIN MONITORING, INC.MYB2020-09-30