Duns Number:053146767
Device Description: The RTC 26-C Inline Aerosol Adapter is designed to assist in the delivery of Combivent® (i 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.
Catalog Number
RTC 26-C
Brand Name
RTC 26-C Inline Aerosol Adapter
Version/Model Number
RTC 26-C
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K162753,K162753,K162753
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
d009352b-b402-4fd1-94c2-42bc76add61d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 06, 2017
Package DI Number
M996RTC26C5
Quantity per Package
50
Contains DI Package
M996RTC26C0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Ziplock bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |