Identity
- Trade Name
- VYGON FDA UDI
- Generic Name
- Airway suction catheter FDA UDI
- Device Name
- Control suction catheter - Ø4.0mm - 12Fr - L.420mm FDA UDI
- Model / Reference
- 535.12 FDA UDI
- Description
- Control suction catheter - Ø4.0mm - 12Fr - L.420mm FDA UDI
Identifiers
- Catalog Number
- 00053512 FDA UDI
- Primary DI / UDI-DI
- 03660812126892 FDA UDI
- FDA Product Code
- BSY FDA UDI
- GMDN Term
- Airway suction catheter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6810 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: Airway suction catheter
A comprehensive Airway Suction Catheter, available in a single-use package with a flexible design for controlled suction. Designed for periodic aspiration of liquids and/or semi-solids from the airway.
Similar devices
Also classified as Airway suction catheter.
- AirLife™ — Airlife, Inc. · Class I
- Closed Suction Catheters — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
- Closed Suction Catheters — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Little Sucker Standard TP — Neotech Products LLC · Class II
- Closed Suction Catheters — Ningbo Xinwell Medical Technology Co., Ltd. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Vygon Corp.
Sources (1)
- FDA UDI 72ce834e-1417-4506-9080-d1908104cfc6 35 fields · synced Jul 23, 2026