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22mm Smoothbore Exhalation Valve Breathing System With Monitoring Line And Swive
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- 22MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVE FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Device Name
- 22MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVEL ELBOW. 1.6M FDA UDI
- Model / Reference
- 5183010 FDA UDI
- Description
- 22MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVEL ELBOW. 1.6M FDA UDI
Identifiers
- Catalog Number
- 5183010 FDA UDI
- Primary DI / UDI-DI
- 05030267165278 FDA UDI
- 510(k) Number
- K132143 FDA UDI
- FDA Product Code
- CBP FDA UDI
- GMDN Term
- Ventilator breathing circuit, single-use 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
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
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
Yes
FDA UDI
Category: Ventilator breathing circuit, single-use
22mm Smoothbore Exhalation Valve Breathing System With Monitoring Line And Swive by Intersurgical Incorporated — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Ventilator breathing circuit, single-use.
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- HUDSON RCI — TELEFLEX INCORPORATED · Class I
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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 REUSABLE EXHALATION VALVE BREATHING SYSTEM WITH 4MM CONTROL LINE — 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 f2e23aed-35f3-4191-b4d6-3f59058917ec 36 fields · synced May 30, 2026