Model 7

FDA UDI

Class II (US FDA UDI)

by Snap Diagnostics, LLC

Identity

Trade Name: Model 7 FDA UDI
Generic Name: Polysomnograph FDA UDI
Device Name: The SNAP Model 7 is a 6 channel data recorder that records respiratory and oximetry data. A canula houses a pressure sensor that records the respiratory air flow and respiratory sounds. An oximeter is integrated into the device and records oxygen saturation and pulse rate. A respiratory effort belt records respiratory effort and optionally can record body position. FDA UDI
Model / Reference: 7-10000 FDA UDI
Description: The SNAP Model 7 is a 6 channel data recorder that records respiratory and oximetry data. A canula houses a pressure sensor that records the respiratory air flow and respiratory sounds. An oximeter is integrated into the device and records oxygen saturation and pulse rate. A respiratory effort belt records respiratory effort and optionally can record body position. FDA UDI

Identifiers

Primary DI / UDI-DI: B577710000 FDA UDI
FDA Product Code: MNR FDA UDI
GMDN Term: Polysomnograph FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.2375 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Polysomnograph

Model 7 by Snap Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Snap Diagnostics, LLC

Sources (1)

FDA UDI 722bc4b5-a7ab-4834-81eb-be34dbd03be2 33 fields · synced Jul 20, 2026