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22mm Smoothbore Reusable Exhalation Valve Breathing System With 4mm Control Line
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- 22MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM WITH 4MM CONTROL LINE FDA UDI
- Generic Name
- Ventilator breathing circuit, reusable FDA UDI
- Device Name
- 22MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM WITH 4MM CONTROL LINE AND 6MM MONITORING LINE 1.8 FDA UDI
- Model / Reference
- 5191000 FDA UDI
- Description
- 22MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM WITH 4MM CONTROL LINE AND 6MM MONITORING LINE 1.8 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05030267069866 FDA UDI
- 510(k) Number
- K132143 FDA UDI
- FDA Product Code
- CBP FDA UDI
- GMDN Term
- Ventilator breathing circuit, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5870 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ventilator breathing circuit, reusable
22mm Smoothbore Reusable Exhalation Valve Breathing System With 4mm Control Line by Intersurgical Incorporated — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Ventilator breathing circuit, reusable.
- KC 042-B - 22mm ID Reusable Ventilator Tubing — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
- KC 004-GG - 22mm ID Reusable Ventilator Tubing — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
- KC 042-3 22mm ID Ventilator Tubing with Integral Cuffs — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
- KC 048-N - 10mm ID Reusable Ventilator Tubing — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
- KC 036-N - 10mm ID Reusable Ventilator Tubing — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
- KC 018-P - 15mm ID Reusable Ventilator Tubing — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
- RESMED — RESMED PTY LTD · Class I
- Vivo Series — Breas Medical AB · Class I
Cleared under the same submission
K132143 also covers:
- 22MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH CONTROL LINE 1.6M — Intersurgical Incorporated
- 22MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE 1.6M — Intersurgical Incorporated
- 22MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVE — Intersurgical Incorporated
- 22MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM. 1.6M — Intersurgical Incorporated
- 22mm Smoothbore breathing system — Intersurgical 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
- Intersurgical Incorporated
Sources (1)
- FDA UDI 275f0c33-9675-4a5a-a59a-575820de217d 35 fields · synced May 31, 2026