Identity
- Trade Name
- Easivent Mask - Large FDA UDI
- Generic Name
- Aerosol face mask, rebreathing, single-use FDA UDI
- Device Name
- The easivent mask is a mask attachment for a Metered Dose Inhaler Spacer. The mask fits directly onto the MDI spacer. The mask is a single piece, injection molded, silicone rubber piece. FDA UDI
- Model / Reference
- 49502-208-03 FDA UDI
- Description
- The easivent mask is a mask attachment for a Metered Dose Inhaler Spacer. The mask fits directly onto the MDI spacer. The mask is a single piece, injection molded, silicone rubber piece. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00349502208034 FDA UDI
- 510(k) Number
- K981167 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Aerosol face mask, rebreathing, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
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, rebreathing, single-use
Easivent Mask - Large by Mylan Specialty L.P. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Aerosol face mask, rebreathing, single-use.
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class I
- MedSource Face Mask — MEDSOURCE INTERNATIONAL LLC · N
- Oxygen Masks — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Procure — Twin Med, LLC · Class I
- System 22 — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class I
- System 22 — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class I
- HUDSON RCI — TELEFLEX INCORPORATED · Class I
Cleared under the same submission
K981167 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mylan Specialty L.P.
Sources (1)
- FDA UDI 78e6841f-a2b3-4c17-abfc-aced69598ecf 35 fields · synced Jun 8, 2026