Identity
- Trade Name
- Aspiration Tube Set FDA UDI
- Generic Name
- Disposable vacuum tubing FDA UDI
- Device Name
- The Perfuze Aspiration Tube Set is a sterile, single-use device consisting of a single flexible braided tube. The tube has a rotating male luer-lock connector on the distal end and a suction connector on the proximal end. The rotating male luer-lock connector connects to the hub of a Millipede 070 Aspiration Catheter. The suction connector connects to the canister of an aspiration pump. A pinch clamp provides the user with the ability to apply vacuum to the catheter. FDA UDI
- Model / Reference
- 1.0 FDA UDI
- Description
- The Perfuze Aspiration Tube Set is a sterile, single-use device consisting of a single flexible braided tube. The tube has a rotating male luer-lock connector on the distal end and a suction connector on the proximal end. The rotating male luer-lock connector connects to the hub of a Millipede 070 Aspiration Catheter. The suction connector connects to the canister of an aspiration pump. A pinch clamp provides the user with the ability to apply vacuum to the catheter. FDA UDI
Identifiers
- Catalog Number
- PA110100US FDA UDI
- Primary DI / UDI-DI
- 05391539370074 FDA UDI
- 510(k) Number
- K232524 FDA UDI
- FDA Product Code
- NRY FDA UDI
- GMDN Term
- Disposable vacuum tubing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 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
No
FDA UDI
Category: Disposable vacuum tubing
Aspiration Tube Set by Perfuze, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Disposable vacuum tubing.
- ProCure — Twin Med, LLC · Class II
- Tube set for vacuum incl. filter, 30-day use — W.O.M. World of Medicine GmbH · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- KAMVAC — DEPUY ORTHOPAEDICS, INC. · Class II
- KAMVAC — DEPUY ORTHOPAEDICS, INC. · Class II
- Tube set for suction, single-use — W.O.M. World of Medicine GmbH · Class II
- Vacuum Pump Tubing — Vitrolife Sweden AB · Class II
- Prabadin — Prabadin Corp · Class II
Cleared under the same submission
K232524 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Perfuze, Ltd.
Sources (1)
- FDA UDI 92275f5c-5956-4939-bb53-64e1105cb8b5 35 fields · synced May 30, 2026