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Apnea Guard

FDA UDI

Class II (US FDA UDI)

by Advanced Brain Monitoring, Inc.

Identity

Trade Name
Apnea Guard FDA UDI
Generic Name
Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Device Name
Apnea Guard Resupply Kit 5L10M20H (V2 OEM) FDA UDI
Model / Reference
AG25-1014 FDA UDI
Description
Apnea Guard Resupply Kit 5L10M20H (V2 OEM) FDA UDI

Identifiers

Primary DI / UDI-DI
00850063034050 FDA UDI
FDA Product Code
ELW FDA UDI
LRK FDA UDI
GMDN Term
Mandible-repositioning sleep-disordered breathing orthosis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3660 FDA UDI
872.5570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Silicone dental impression materialMandible-repositioning sleep-disordered breathing orthosis

Apnea Guard by Advanced Brain Monitoring, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mandible-repositioning sleep-disordered breathing orthosis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advanced Brain Monitoring, Inc.

Sources (1)

  • FDA UDI d943b970-9fe4-404a-8cb2-f4fc4410b83f 34 fields · synced Jun 8, 2026