Identity
- Trade Name
- BVF FDA UDI
- Generic Name
- Breathing mouthpiece, single-use FDA UDI
- Device Name
- 2820 BVF FDA UDI2820 ECO BVF WITH BITE LIP FDA UDI
- Model / Reference
- 2820 FDA UDI
- Description
- 2820 BVF FDA UDI2820 ECO BVF WITH BITE LIP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15099169284354 FDA UDI15099169285542 FDA UDI
- 510(k) Number
- K942779 FDA UDI
- FDA Product Code
- BZG FDA UDI
- GMDN Term
- Breathing mouthpiece, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1840 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Breathing mouthpiece, single-use
Bvf by Vitalograph Ireland, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Breathing mouthpiece, single-use.
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- Mouthpiece, Disposable, 1.125" ID, 2.5" L — A-M Systems, Inc. · Class I
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- EasySpeak — Intersurgical Incorporated · Class I
- All Flow Adult Disp Mthpc. — ALLIANCE TECH MEDICAL, INC. · Class I
- Mouthpiece, Disposable, 3/4" O.D., 2.625" L — A-M Systems, Inc. · Class I
- Mouthpiece, Disposable, 1-1/16" O.D., 2.625" L — A-M Systems, Inc. · Class I
Cleared under the same submission
K942779 also covers:
- BVF — Vitalograph Ireland, Ltd.
- BVF — Vitalograph Ireland, Ltd.
- BVF — Vitalograph Ireland, Ltd.
- BVF — Vitalograph Ireland, Ltd.
- BVF — Vitalograph Ireland, Ltd.
- BVF — Vitalograph Ireland, Ltd.
- BVF — Vitalograph Ireland, Ltd.
- BVF — Vitalograph Ireland, Ltd.
- BVF — Vitalograph Ireland, Ltd.
- BVF — Vitalograph Ireland, Ltd.
- BVF — Vitalograph Ireland, Ltd.
- BVF — Vitalograph Ireland, Ltd.
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
- Vitalograph Ireland, Ltd.
Sources (2)
- FDA UDI 285d91c2-69d7-4138-b8fe-1bd6d1c84ad3 34 fields · synced Jun 1, 2026
- FDA UDI 4d417b06-74c7-4e38-8eea-e0e39bb9c1e3 34 fields · synced May 22, 2026