Eu Mdr Eu Md Class 1 On The Market 🇨🇳 China

PINECY® Inflation Device for Balloon Catheters

Devices (same UDI-DI)
2
Certificates
0
Countries
1
Notified Bodies
0

Basic Information

Primary DI
06935456211943
Basic UDI-DI Code
69354562PLYL10XC
Reference
FA10001
Device Types
Single use Sterile
Regulation
Eu Mdr
Classification
Eu Md Class 1
Status
On The Market

Additional Description

Inflation Device for Balloon Catheters is a product that assists balloon expansion. The effective volume is 20ml. There are two specifications of 30atm and 40atm. Before use, connect the three-way cock of the Inflation Device with the balloon catheter connector. After confirming the connection, rotate the Inflation Device. The handle pressurizes the balloon clockwise to increase the diameter of the balloon. Pay attention to the value of the pressure gauge in real time, and stop rotating the handle when the pressure reaches the specified pressure. When the balloon expansion is complete, turn the handle counterclockwise until the pressure gauge returns to zero.

CND Nomenclature Codes

Code Description
V901699 SPECIALIST SURGICAL INSTRUMENTS AND KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE - OTHER

Available In Countries

🇹🇷 Türkiye

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