Identity
- Trade Name
- RTC 22-A Metered Dose Inhaler Adapter FDA UDI
- Generic Name
- Metered dose inhaler FDA UDI
- Device Name
- The Instrumentation Industries, Inc. RTC 22-A is an actuator for intermittent delivery of prescribed aerosol medication dispensed in metered dose inhalers. The RTC 22-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 22-A Adapter 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 22-A FDA UDI
- Description
- The Instrumentation Industries, Inc. RTC 22-A is an actuator for intermittent delivery of prescribed aerosol medication dispensed in metered dose inhalers. The RTC 22-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 22-A Adapter is intended for Single Patient Reuse. This device is intended for sale by or on the order of a physician. FDA UDI
Identifiers
- Catalog Number
- RTC 22-A FDA UDI
- Primary DI / UDI-DI
- M996RTC22A0 FDA UDI
- 510(k) Number
- K991355 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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 22-A Metered Dose Inhaler Adapter by Instrumentation Industries, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metered dose inhaler.
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- RTC 15-P Metered Dose Inhaler Adapter — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
- RTC 23-D Metered Dose Inhaler Adapter — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
- RTC 24-VP Universal Metered Dose Inhaler Adapter — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
- RTC 24-V Universal Metered Dose Inhaler Adapter Kit — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
Cleared under the same submission
K991355 also covers:
- RTC 15-D Metered Dose Inhaler Adapter — INSTRUMENTATION INDUSTRIES, INCORPORATED
- RTC 15-P Metered Dose Inhaler Adapter — INSTRUMENTATION INDUSTRIES, INCORPORATED
- RTC 22-D Metered Dose Inhaler Adapter — INSTRUMENTATION INDUSTRIES, INCORPORATED
- RTC 23-A Metered Dose Inhaler Adapter — INSTRUMENTATION INDUSTRIES, INCORPORATED
- RTC 23-D Metered Dose Inhaler Adapter — INSTRUMENTATION INDUSTRIES, INCORPORATED
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Instrumentation Industries, Incorporated
Sources (1)
- FDA UDI d11aec35-ebc2-4609-877c-2fcb66b30910 36 fields · synced Jun 8, 2026