Identity
- Trade Name
- Apnea Guard EUDAMEDFDA UDI
- Generic Name
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
- Device Name
- Apnea Guard EUDAMEDApnea Guard Starter Kit 1L3M1H Spanish FDA UDI
- Model / Reference
- AG25-1009(SPA) EUDAMEDFDA UDI
- Description
- Apnea Guard Starter Kit 1L3M1H Spanish FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850015266430 EUDAMEDFDA UDI
- Basic UDI-DI
- 0851113007AG25SPPJ9 EUDAMED
- 510(k) Number
- K111110 FDA UDI
- FDA Product Code
- LRK FDA UDI
- EMDN Code
- Q03010299 ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER EUDAMED
- GMDN Term
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.5570 FDA UDI
- Medical Purpose
- The Apnea Guard is a mandibular repositioning device intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years and older. The Apnea Guard is intended to be fitted with assistance from a healthcare professional, and used during sleep for less than 30-nights. EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Apnea Guard by Advanced Brain Monitoring, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0851113007AG25SPPJ9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advanced Brain Monitoring, Inc.
- EUDAMED SRN
- US-PR-000044717
Sources (2)
- EUDAMED e6a1386d-9f32-4347-8676-aaaf6a139949 61 fields · synced Oct 6, 2026
- FDA UDI cee5fe98-2fdb-4aad-9ef4-b15c4d50fd8a 35 fields · synced May 30, 2026