Identity
- Trade Name
- Medline FDA UDI
- Generic Name
- Aerosol face mask, non-rebreathing FDA UDI
- Device Name
- MASK,AEROSOL,ELONGATED,ADULT,SWIVEL FDA UDI
- Model / Reference
- HCS4630 FDA UDI
- Description
- MASK,AEROSOL,ELONGATED,ADULT,SWIVEL FDA UDI
Identifiers
- Catalog Number
- HCS4630 FDA UDI
- Primary DI / UDI-DI
- 10080196715411 FDA UDI
- FDA Product Code
- BYG FDA UDIKGB FDA UDI
- GMDN Term
- Aerosol face mask, non-rebreathing FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5580 FDA UDI868.5570 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Aerosol face mask, non-rebreathing
Medline by Medline Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Aerosol face mask, non-rebreathing.
- Aerosol Masks — WESTMED, INC. · Class I
- BF — Allied Medical LLC · Class I
- Mask — WESTMED, INC. · Class I
- Mask — WESTMED, INC. · Class I
- MedSource Aerosol Mask — MEDSOURCE INTERNATIONAL LLC · Class I
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- AOSHANG — Tianjin Aoshang Outdoor Equipment Co., Ltd. · Class II
- AMSure® Aerosol Drainage System — AMSINO INTERNATIONAL, INC. · Class I
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
- Medline Industries, Inc.
Sources (1)
- FDA UDI 4a9aa226-398e-4cad-aba7-8a3f9174c02e 36 fields · synced May 29, 2026