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RTC 24-V Universal Metered Dose Inhaler Adapter Kit

FDA UDI

Class II (US FDA UDI)

by Instrumentation Industries, Incorporated

Identity

Trade Name
RTC 24-V Universal Metered Dose Inhaler Adapter Kit FDA UDI
Generic Name
Metered dose inhaler FDA UDI
Device Name
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. FDA UDI
Model / Reference
RTC 24-V Kit FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
M996RTC24VKIT0 FDA UDI
510(k) Number
K091111 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

Yes

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

Category: Metered dose inhaler

RTC 24-V Universal Metered Dose Inhaler Adapter Kit by Instrumentation Industries, Incorporated — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Metered dose inhaler.

Cleared under the same submission

K091111 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Instrumentation Industries, Incorporated

Sources (1)

  • FDA UDI 903fe1c3-105d-4409-aa41-125b80b597a3 35 fields · synced May 30, 2026