Identity
- Trade Name
- RTC 26-C Inline Aerosol Adapter FDA UDI
- Generic Name
- Metered dose inhaler FDA UDI
- Device Name
- The RTC 26-C Inline Aerosol Adapter is designed to assist in the delivery of Combivent® (ipratropium bromide and albuterol) medication from a Respimat® inhaler as prescribed to an adult, mechanically-ventilated patient. The RTC 26-C Inline Aerosol Adapter is intended for use only when connected to ventilator tubing. The RTC 26-C Inline Aerosol Adapter is intended for single patient reuse. This device is intended for sale by or on the order of a physician. FDA UDI
- Model / Reference
- RTC 26-C FDA UDI
- Description
- The RTC 26-C Inline Aerosol Adapter is designed to assist in the delivery of Combivent® (ipratropium bromide and albuterol) medication from a Respimat® inhaler as prescribed to an adult, mechanically-ventilated patient. The RTC 26-C Inline Aerosol Adapter is intended for use only when connected to ventilator tubing. The RTC 26-C Inline Aerosol Adapter is intended for single patient reuse. This device is intended for sale by or on the order of a physician. FDA UDI
Identifiers
- Catalog Number
- RTC 26-C FDA UDI
- Primary DI / UDI-DI
- M996RTC26C0 FDA UDI
- 510(k) Number
- K162753 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Metered dose inhaler 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Hydrogen Peroxide FDA UDI
Category: Metered dose inhaler
RTC 26-C Inline Aerosol Adapter by Instrumentation Industries, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Instrumentation Industries, Incorporated
Sources (1)
- FDA UDI d009352b-b402-4fd1-94c2-42bc76add61d 36 fields · synced Jun 8, 2026