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22mm Smoothbore Exhalation Valve Heated Wire Breathing System With Limb.1.6m
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- 22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH LIMB.1.6M FDA UDI
- Generic Name
- Ventilator breathing circuit, single-use FDA UDI
- Device Name
- 22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH LIMB.1.6M FDA UDI
- Model / Reference
- 5194850 FDA UDI
- Description
- 22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH LIMB.1.6M FDA UDI
Identifiers
- Catalog Number
- 5194850 FDA UDI
- Primary DI / UDI-DI
- 05030267069972 FDA UDI
- 510(k) Number
- K092129 FDA UDI
- FDA Product Code
- BZE FDA UDI
- GMDN Term
- Ventilator breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5270 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
MR Unsafe FDA UDI
Category: Ventilator breathing circuit, single-use
22mm Smoothbore Exhalation Valve Heated Wire Breathing System With Limb.1.6m 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
K092129 also covers:
- 22MM FLEXTUBE DUAL H/W B/S WITH AUTO-FILL CHAMBER AND EXTRA LIMBS. >1.6M — Intersurgical Incorporated
- 22MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM WITH EXTRA LIMBS.>1.6M — Intersurgical Incorporated
- 22MM FLEXTUBE SINGLE H/W LIMB WITH AUTO-FILL CHAMBER AND EXTRA LIMB.>1.6M — Intersurgical Incorporated
- 22MM SMOOTHBORE DUAL H/W BREATHING SYSTEM WITH EXTRA LIMB. > 1.6M — Intersurgical Incorporated
- 22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE — Intersurgical Incorporated
- 22MM SMOOTHBORE SINGLE H/W B/S WITH WATER TRAP, AUTO-FILL CHAMBER, EXTRA LIMB>1.6M — Intersurgical Incorporated
- 22MM SMOOTHBORE SINGLE H/W BREATHING SYSTEM WITH WATER TRAP AND LIMB.>1.6M — 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 4326f86a-1e2f-4472-a15c-4270583b0527 36 fields · synced May 30, 2026