FDA.reportPublic FDA data

Night Shift

Primary DI
00850015266232
Brand
Night Shift
Company
ADVANCED BRAIN MONITORING, INC.
Model
NS27-1005.LE(TCHI)
Device description
Night Shift LE Device Kit - Traditional Chinese
Published
2021-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MNRVentilatory Effort Recorder
MYBPillow,Cervical(For Mild Sleep Apnea)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNRVentilatory Effort RecorderAnesthesiology2
MYBPillow, Cervical (For Mild Sleep Apnea)Dental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140190000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140190000NIGHT SHIFTAdvanced Brain Monitoring, Inc.2014-05-29MYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850015266232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850015266232008500152662328500152662320850015266232

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
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
969842715
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850063034401Sleep Profiler PSG2SP29-1017.LE2026-09-25
00850063034418Sleep Profiler PSG2SP29-1018.LE2026-09-25
00850063034425Sleep ProfilerSP29-1020.LE2026-09-25
00850063034432Sleep ProfilerSP29-1020.LE(ITA)2026-09-25
00850063034449Sleep ProfilerSP29-1021.LE2026-09-25
00850063034456Sleep ProfilerSP29-1022.LE2026-09-25
00850063034470Sleep ProfilerSP29-1025.LE2026-09-25
00850063034487Sleep ProfilerSP29-1026.LE2026-09-25
00850063034494Sleep ProfilerSP29-1027.LE2026-09-25
00850063034524Sleep ProfilerSP29-1020.LE(GER)2026-09-25
00850063034364Sleep ProfilerSP40-1001.LE(GRE)2025-12-22
00850063034296Night ShiftNS27-1010.LE2025-12-08
00850063034319Night ShiftNS27-1005.LE(FIN)2025-12-08
00850063034326Night ShiftNS27-1005.LE(NOR)2025-12-08
00850063034333Night ShiftNS27-1005.LE(SWE)2025-12-08
00850063034357Night ShiftNS27-1010.LE(FRE)2025-12-08
00850063034340Night ShiftNS27-1010.LE(ENSO)2025-11-14
70850015266194Night ShiftNS27-1005.LE(ENSO)2025-10-27
00850063034302Night ShiftNS27-1005.LE(DAN)2025-08-21
00850063034272Night ShiftNS27-41022025-07-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08885021950013TipTraQPRANAQ PTE. LTD.MNR2026-05-18
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08720256698296Onera STS 2Onera B.V.MNR2026-05-15
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08720256698463Onera STSOnera B.V.MNR2026-05-15
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