Duns Number:053146767
Device Description: The Instrumentation Industries, Inc. RTC 21-A Metered Dose Inhaler Adapter is intended for The Instrumentation Industries, Inc. RTC 21-A Metered Dose Inhaler Adapter is intended for use in intermittent aerosol therapy to deliver aerosol medications (in compressed canister MDIs) via the proximal end of an endotracheal tube.The RTC 21-A MDI Adapter is intended for reuse. This device is intended for sale by or on the order of a physician.
Catalog Number
-
Brand Name
RTC 21-A Metered Dose Inhaler Adapter
Version/Model Number
RTC 21-A
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
-
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
K981249,K981249,K981249
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
c822e53f-0032-4500-adb7-1b60609e0d60
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 30, 2016
Package DI Number
M996RTC21A2
Quantity per Package
10
Contains DI Package
M996RTC21A0
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 |