FDA.reportPublic FDA data

Night Shift

Primary DI
00851113007031
Brand
Night Shift
Company
ADVANCED BRAIN MONITORING, INC.
Model
NS27-1005.R
Device description
Night Shift Device Kit - Refurbished
Published
2019-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
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
00851113007031Direct MarkingGS10
20851113007035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851113007031008511130070318511130070310851113007031
2085111300703520851113007035

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
969842715
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00850063034289Night ShiftNS27-4102.XXL2025-07-21
00850015266492Night ShiftNS27-41022022-03-29
00850015266508Night ShiftNS27-4102.XXL2022-03-29
00850063034265Night ShiftNS27-1010.LE2025-05-22
00851113007123Apnea GuardAG25-4107.202016-09-23
00850063034135X-SeriesXS30-1015.LE2025-01-29
00850063034166X-SeriesXS30-1001.LE2025-01-29
00850063034180X-SeriesXS30-1007.LE2025-01-29
00850063034128Sleep ProfilerSP29-1015.LE2025-01-28
00850063034142Sleep Profiler PSG2SP29-1002.LE2025-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850063034296Night ShiftADVANCED BRAIN MONITORING, INC.MYB2025-12-08
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