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EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN FDA UDI
- Generic Name
- Therapeutic agent nebulizer, benchtop FDA UDI
- Device Name
- EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN FDA UDI
- Model / Reference
- 105514 FDA UDI
- Description
- EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN FDA UDI
Identifiers
- Catalog Number
- 10551494010 FDA UDI
- Primary DI / UDI-DI
- 62860105514020 FDA UDI
- 510(k) Number
- K080926 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Therapeutic agent nebulizer, benchtop FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5630 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Over-the-Counter
Yes
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
EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN by Trudell Medical International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- Trudell Medical International
Sources (1)
- FDA UDI 643d904b-c6b8-4a2c-86b8-dea99b54df43 37 fields · synced Jun 8, 2026