Duns Number:053146767
Device Description: The Instrumentation Industries, Inc. RTC 24-V KIT includes the RTC 24-V MDI Adapter actuat The Instrumentation Industries, Inc. RTC 24-V KIT includes the RTC 24-V MDI Adapter actuator for intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style metered dose inhalers. The RTC 24-V KIT is intended for use only when connected to ventilator tubing or tracheal tubes. The RTC 24-V KIT is intended to be prescribed for any patient who is ventilator-dependent and to whom a metered dose inhaler has been prescribed. The expected clinical environment for the RTC 24-V KIT is Critical Care and/or long term or short term ventilation.The components of the RTC 24-V KIT consist of one RTC 24-V MDI Adapter, one four inch length of 22mm inner-diameter tubing, and one 15mm inner-diameter/22mm outer-diameter adapter. The RTC 24-V KIT is intended for single patient reuse. This device is intended for sale by or on the order of a physician.
Catalog Number
-
Brand Name
RTC 24-V Universal Metered Dose Inhaler Adapter Kit
Version/Model Number
RTC 24-V Kit
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
K091111,K091111
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
903fe1c3-105d-4409-aa41-125b80b597a3
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 08, 2016
Package DI Number
M996RTC24VKIT2
Quantity per Package
10
Contains DI Package
M996RTC24VKIT0
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 |