Identity
- Trade Name
- Nebulizer,pacifier FDA UDI
- Generic Name
- Breathing mouthpiece, single-use FDA UDI
- Device Name
- Nebulizer,pacifier FDA UDI
- Model / Reference
- MP-79120 FDA UDI
- Description
- Nebulizer,pacifier FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04716770791203 FDA UDI
- FDA Product Code
- BYP FDA UDI
- GMDN Term
- Breathing mouthpiece, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5620 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Breathing mouthpiece, single-use
Nebulizer, pacifier by Besmed Health Business Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Breathing mouthpiece, single-use.
- Astraguard — SDI DIAGNOSTICS, INC. · Class II
- Mouthpiece, Disposable, .900"OD, 2.50" L — A-M Systems, Inc. · Class I
- Mouthpiece, Disposable, 1.125" ID, 2.5" L — A-M Systems, Inc. · Class I
- PFT — Vitalograph Ireland, Ltd. · Class II
- Disposable Mouthpiece 27mm OD — Vacumed · Class I
- EasySpeak — Intersurgical Incorporated · Class I
- All Flow Adult Disp Mthpc. — ALLIANCE TECH MEDICAL, INC. · Class I
- PFT — Vitalograph Ireland, Ltd. · Class II
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Besmed Health Business Corp.
Sources (1)
- FDA UDI 78643333-a986-4c15-8660-03f7e5bde228 33 fields · synced Jun 8, 2026