Identity
- Trade Name
- RUSCH FDA UDI
- Generic Name
- Anaesthesia breathing circuit, reusable FDA UDI
- Device Name
- Connecting Tube FDA UDI
- Model / Reference
- IPN004567 FDA UDI
- Description
- Connecting Tube FDA UDI
Identifiers
- Catalog Number
- 230100-000000 FDA UDI
- Primary DI / UDI-DI
- 04026704034543 FDA UDI
- 510(k) Number
- K951046 FDA UDI
- FDA Product Code
- BSK FDA UDI
- GMDN Term
- Anaesthesia breathing circuit, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Anaesthesia breathing circuit, reusable
Rusch by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia breathing circuit, reusable.
- Ultipor™ Anesthesia Breathing Circuit System - Adult Machine Kit — Global Life Sciences Solutions USA LLC · Class II
- MATRX SCAV, W/SM HOOD(WO/SHUTOF — Parker Hannifin Corp. · Class I
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- Sil.Plus — Galemed Corp. · Class I
- PORTER/BRN ADULT RG ASSY ONLY — Parker Hannifin Corp. · Class I
- Ultipor™ Anesthesia Breathing Circuit System - Adult Machine Kit — Global Life Sciences Solutions USA LLC · Class II
- 30MM UNIFLOW COAXIAL BREATHING SYSTEM WITH LUER ELBOW, AND LIMB, 2.4M — Intersurgical Incorporated · Class I
- Ultipor™ Anesthesia Breathing Circuit System - Pediatric Machine Kit — Global Life Sciences Solutions USA LLC · Class II
Cleared under the same submission
K951046 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
- Teleflex Incorporated
Sources (1)
- FDA UDI 8366ce42-f8f5-4213-9f19-94dccc8ae469 36 fields · synced May 30, 2026