Identity
- Trade Name
- One Mask™ Oxygen Mask FDA UDI
- Generic Name
- Nebulizing system delivery set, single-use FDA UDI
- Device Name
- One Mask™ Oxygen Mask Mask, Adapter, 79’’(200cm) Standard O2 Connector Oxygen Tubing w/Label. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- One Mask™ Oxygen Mask Mask, Adapter, 79’’(200cm) Standard O2 Connector Oxygen Tubing w/Label. FDA UDI
Identifiers
- Catalog Number
- OM004 FDA UDI
- Primary DI / UDI-DI
- 10704411008903 FDA UDI
- FDA Product Code
- BYG FDA UDI
- GMDN Term
- Nebulizing system delivery set, single-use 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
No
FDA UDI
Category: Nebulizing system delivery set, single-use
One Mask™ Oxygen Mask by Amsino International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nebulizing system delivery set, single-use.
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- NEBULISER ANGLED MOUTHPIECE 22M-22M — Intersurgical Incorporated · Class I
- KENOREX — KENTRON HEALTH CARE, INC. · Class II
- MedSource Nebulizer — MEDSOURCE INTERNATIONAL LLC · Class I
- Medline — MEDLINE INDUSTRIES, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Amsino International, Inc.
Sources (1)
- FDA UDI 18bccfda-c0ad-420d-af86-44baa59675ac 34 fields · synced Jun 8, 2026