Identity
- Trade Name
- ONE PIECE AEROSOL MASK, CHILD, ELEPHANT DESIGN FDA UDI
- Generic Name
- Respiratory oxygen therapy system FDA UDI
- Device Name
- ONE PIECE AEROSOL MASK, CHILD, ELEPHANT DESIGN FDA UDI
- Model / Reference
- OM-82420 FDA UDI
- Description
- ONE PIECE AEROSOL MASK, CHILD, ELEPHANT DESIGN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04716770824208 FDA UDI
- FDA Product Code
- BYG FDA UDI
- GMDN Term
- Respiratory oxygen therapy system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5580 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: Respiratory oxygen therapy system
One Piece Aerosol Mask, Child, Elephant Design by Besmed Health Business Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Respiratory oxygen therapy system.
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- O2-RESQ — Pulmodyne Inc. · Class II
- O2-MAX — Pulmodyne Inc. · Class II
- Infant Flow™ — VYAIRE MEDICAL, INC. · Class II
- AincA — Anesthesia Associates, Inc. · Class II
- Infant Flow — VYAIRE MEDICAL, INC. · 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 |
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Manufacturer
- Manufacturer
- Besmed Health Business Corp.
Sources (1)
- FDA UDI f6bf99c9-b92b-4776-a2d2-d245d5050b60 33 fields · synced May 30, 2026