FDA.reportPublic FDA data

Sleep Profiler

Primary DI
00851113007949
Brand
Sleep Profiler
Company
ADVANCED BRAIN MONITORING, INC.
Model
SP40-1001.LE, SP29-1003.LE
Device description
Sleep Profiler LE Device Kit
Published
2019-10-15
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
OMCReduced- Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMCReduced- Montage Standard ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152040000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152040000X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29)Advanced Brain Monitoring, Inc.2015-10-30OMC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851113007949Direct MarkingGS10
00851113007956PrimaryGS10
00851113007963PrimaryGS10
00851113007970PrimaryGS10
00851113007987PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851113007949008511130079498511130079490851113007949
00851113007956008511130079568511130079560851113007956
00851113007963008511130079638511130079630851113007963
00851113007970008511130079708511130079700851113007970
00851113007987008511130079878511130079870851113007987

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographA line-powered device used to record the variations of the electrical potential caused by the electrical activity of the brain, usually detected at the patient's scalp. Leads affixed to the scalp and ear lobes transmit the electric signals to the recorder, which in turn reproduces their characteristics in an electroencephalogram (EEG). They are used to study a variety of neurological conditions, evaluate psychiatric disorders and assist in localizing tumours or lesions on or near the surface of the brain.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

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
true
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850063034401Sleep Profiler PSG2ADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034418Sleep Profiler PSG2ADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034425Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034432Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034449Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034456Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034470Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034487Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034494Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00850063034524Sleep ProfilerADVANCED BRAIN MONITORING, INC.OMC2026-09-25
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.OMC2026-09-04
00850011306314ATLAS Cart - Dual MonitorsNEURALYNX, INC.OMC2026-04-27
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05999860882053QUEX SQX WORLD LTDOMC2026-04-27
05999860882060QUEX EDQX WORLD LTDOMC2026-04-27
05999860882077QUEX SQX WORLD LTDOMC2026-04-27
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00840682147811CARESCAPE SoftwareGE Healthcare Finland OyOMC2026-04-15
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09357225002014Nurochek-Pro HeadsetHEADSAFE MFG PTY LTDOMC2026-03-18
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09342451002822Compumedics SomfitCOMPUMEDICS LIMITEDOMC2026-03-12
09342451002860Compumedics SomfitCOMPUMEDICS LIMITEDOMC2026-03-12
09342451007063Compumedics Somfit DCOMPUMEDICS LIMITEDOMC2026-03-12
09357225000041Nurochek-ProHEADSAFE MFG PTY LTDOMC2026-01-23