FDA.reportPublic FDA data

Sleepsense

Primary DI
07290013820488
Brand
Sleepsense
Company
SLP INC
Model
9010A5-Kit
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290013820488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290013820488072900138204887290013820488

GMDN Terms#

Term, Definition table
TermDefinition
Polysomnography analyserA mains electricity (AC-powered) device designed to record and interpret a variety of physiologic functions during sleep to evaluate sleep/sleep-related disorders (e.g., insomnia, hypersomnia, apnoea). It typically performs electroencephalography, electrocardiography, electro-oculography, electromyography, and respiration, temperature, and pulse oximetry readings. It may also provide audiovisual information about the sleeping patient for behavioral analysis and other measurements (e.g., gastric reflux, bedwetting). The device includes electrodes, measuring instruments, samplers, filters, amplifiers, and appropriate software for processing data and providing patient diagnoses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023572393
Device count
1
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290013818829NatusNA-13402016-09-20
07290013818836NatusNA-13412016-09-20
07290013818843NatusNA-15502016-09-20
07290013820464Sleepsense9100A5BP-Kit2016-09-20
07290008986526Sleepsense 1370-Kit 2016-09-20
07290008986533Sleepsense 1388-Kit 2016-09-20
07290008986540Sleepsense 1387-Kit 2016-09-20
07290008986601Sleepsense 1770-Kit 2016-09-20
07290008986618Sleepsense 1772-Kit 2016-09-20
07290008986632Sleepsense 9101PTP-Kit 2016-09-20
07290012144325Sleepsense 1368-Kit 2016-09-20
07290012144332Sleepsense 1369-Kit 2016-09-20
07290012144349Sleepsense 1391-Kit 2016-09-20
07290012144356Sleepsense 1389-KIT 2016-09-20
07290012144363Sleepsense 1450-KIT 2016-09-20
07290012144431Sleepsense 1399-Kit 2016-09-20
07290012144448Sleepsense 1398-Kit 2016-09-20
07290012144455Sleepsense 1397-Kit 2016-09-20
07290012144462Sleepsense 1396-Kit 2016-09-20
07290012144479Sleepsense 1771-2-Kit 2016-09-20