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REUSABLE COMFORTSEAL® Silicone Mask Assembly
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- REUSABLE COMFORTSEAL® Silicone Mask Assembly FDA UDI
- Generic Name
- Aerosol face mask, rebreathing, single-use FDA UDI
- Device Name
- REUSABLE COMFORTSEAL® Silicone Mask Assembly – Small For use with the family of AeroEclipse® nebulizers FDA UDI
- Model / Reference
- 105503 FDA UDI
- Description
- REUSABLE COMFORTSEAL® Silicone Mask Assembly – Small For use with the family of AeroEclipse® nebulizers FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00762860055032 FDA UDI
- FDA Product Code
- BYG FDA UDI
- GMDN Term
- Aerosol face mask, rebreathing, 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
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
No
FDA UDI
Category: Aerosol face mask, rebreathing, single-use
REUSABLE COMFORTSEAL® Silicone Mask Assembly by Trudell Medical International — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Trudell Medical International
Sources (2)
- FDA UDI 032b914b-309f-4ea0-956f-be26d5bc13da 34 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 3, 2026