Model 9

Primary DI: B577910000
Brand: Model 9
Company: SNAP DIAGNOSTICS
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: New
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
OTC: false
Sterile: false
Single use: false

Related Records

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
B577910000	Primary	HIBCC	0

GMDN Terms

Term	Definition
Home-use sleep apnoea recording system	A 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.

Term

Definition

Home-use sleep apnoea recording system

A 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

Regulatory Flags

DUNS number: 827445854
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	Catalog	Published
B577710000	Model 7	7-10000		2017-08-18
B577810000	Model 8	8-10000		2017-08-18