DEVICE: RTC 23-A Metered Dose Inhaler Adapter (M996RTC23A0)
Device Identifier (DI) Information
RTC 23-A Metered Dose Inhaler Adapter
RTC 23-A
In Commercial Distribution
RTC 23-A
INSTRUMENTATION INDUSTRIES, INCORPORATED
RTC 23-A
In Commercial Distribution
RTC 23-A
INSTRUMENTATION INDUSTRIES, INCORPORATED
The Instrumentation Industries, Inc. RTC 23-A is an actuator for intermittent delivery of prescribed aerosol medication dispensed in metered dose inhalers. The RTC 23-A Adapter is intended for use only when connected to ventilator tubing or tracheal tubes.
For use with metered dose inhaler canisters with standard size metal or plastic stems.
The RTC 23-A Adapter is intended for Single Patient Reuse.
This device is intended for sale by or on the order of a physician.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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35122 | Metered dose inhaler |
A hand-held device designed to administer a pre-measured dose of aerosolized medication directly into the mouth of a patient. It typically consists of a shaped plastic holder with integrated mouthpiece into which a pressurized metal canister containing the solution or suspension of medicine is placed. Commonly known as a metered dose inhaler (MDI), aerosol inhaler or puffer, it is a portable device typically carried in the pocket or a handbag (purse) of the patient for convenient access. A medicine chamber spacer may be attached to this device to facilitate its use by small children (enables the slow inhalation of the medicine). This is a reusable device intended for single-patient use.
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FDA Product Code
[?]Product Code | Product Code Name |
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CAF | Nebulizer (Direct Patient Interface) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K991355 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
245fd40d-ac17-4d4b-a0d6-7cf33929545d
July 06, 2018
3
August 08, 2016
July 06, 2018
3
August 08, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
M996RTC23A2 | 10 | M996RTC23A0 | In Commercial Distribution | Ziplock Bag | |
M996RTC23A1 | 5 | M996RTC23A0 | In Commercial Distribution | Ziplock Bag |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
412-854-1133
raqa@iiimedical.com
raqa@iiimedical.com