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Breathbite Mouthpiece, Disposable , Tongue Depressing
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 164950Model Disposable Rubber Mouthpiece
Identity
- Trade Name
- Breathebite EUDAMEDBreathbite Mouthpiece, Disposable , Tongue Depressing FDA UDI
- Generic Name
- Breathing mouthpiece, single-use FDA UDI
- Device Name
- Disposable Rubber Mouthpiece EUDAMEDMouthpiece, Disposable , White, Thermoplastic, Tongue Depressing, Breathbite FDA UDI
- Model / Reference
- Disposable Rubber Mouthpiece EUDAMED164950 EUDAMEDBreathbite Mouthpiece - 164950 FDA UDI
- Description
- Mouthpiece, Disposable , White, Thermoplastic, Tongue Depressing, Breathbite FDA UDI
Identifiers
- Catalog Number
- 164950 FDA UDI
- Primary DI / UDI-DI
- 00817081027037 EUDAMEDFDA UDI
- Basic UDI-DI
- 0817081021649XXFR EUDAMED
- FDA Product Code
- BYP FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Breathing mouthpiece, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5620 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Breathing mouthpiece, single-use
Breathbite Mouthpiece, Disposable , Tongue Depressing by A-M Systems, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Breathing mouthpiece, single-use.
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- PFT — Vitalograph Ireland, Ltd. · Class II
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- Safe-T-Way — Vitalograph Ireland, Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- A-M Systems, Inc.
Sources (2)
- FDA UDI d973c8c2-71ec-4a74-b689-145804c26ddd 35 fields · synced Jul 10, 2026
- EUDAMED 66cc068a-70f0-431d-a3ec-cb5ed5ab26eb 61 fields · synced Jul 10, 2026