Identity
- Trade Name
- RTC 21-A Metered Dose Inhaler Adapter FDA UDI
- Generic Name
- Metered dose inhaler FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- RTC 21-A FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M996RTC21A0 FDA UDI
- 510(k) Number
- K981249 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 21-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.
- SINGLE SPRAY MDI ADAPTER — THAYER MEDICAL CORPORATION · Class I
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- AEROCHAMBER mini Holding Chamber — Trudell Medical International · Class II
- TELEFLEX MINISPACER — THAYER MEDICAL CORPORATION · Class II
- 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
K981249 also covers:
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 c822e53f-0032-4500-adb7-1b60609e0d60 35 fields · synced Jun 1, 2026