Model 9

Primary DI
B577910000
Brand
Model 9
Company
SNAP DIAGNOSTICS LLC
Model
9-10000
Device description
The Snap Model 9 device is a wearable at home sleep recorder intended to record airflow, breathing effort and body position and is indicated for use and an aid for diagnostic evaluation of patient for sleep apnea and snoring.
Published
2026-02-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B577910000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Home-use sleep apnoea recording systemA battery-powered device assembly intended to continuously measure and record patient physiological parameters (e.g., arterial oxygen saturation level, pulse rate, respiration effort/pattern, airflow waveform) during sleep in the home, to facilitate the diagnosis of sleep apnoea [e.g., obstructive sleep apnoea (OSA)]. It includes primary components such as sensors (e.g., air pressure sensor) and/or a control unit which may have some user-interface functionality, and typically additional devices which may include a gas sampling face mask and/or connecting leads/cables; collected data is transferred to a central database or computerized device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
945853828
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B577710000Model 77-100002017-08-18
B577810000Model 88-100002017-08-18