Disposable Endoscopic Stone Extraction Balloon with CE Certification

• Type: Disposable Medical Supplies
• Material: Nr, Pebax
• Ethylene Oxide Sterilization: Ethylene Oxide Sterilization
• Quality Guarantee Period: Two Years
• Group: Adult or Children
• Logo Printing: Customized
• Model NO.: JHY-BAL
• Certification: CE, SGS, FDA, ISO13485
• Medical Device Regulatory Type: Type 2
• Tube Diameter: 2.3mm
• Balloon Size: 8.5/11.5/15, 9/12/15, 11/13/15, 10/13/16
• Working Length: 2000mm
• Endoscope Channel: 3.2mm
• Lumen No.: 3
• Transport Package: 1PC/Bag
• Specification: CE, ISO
• Trademark: JIUHONG, OEM, GLOBAL
• Origin: Changzhou, Jiangsu
• HS Code: 9018909010
• Production Capacity: 100000PCS

Product Description

Disposable Stone Extraction Balloon with CE Certification










1. Intended Use:
Stone removal in biliary tract, including biliary sludge and residual gallstone left in biliary tract after Mechanical Lithotripsy.


2. Characteristics:
* Innovational design of three lumens(lumens for guide wire, injection and inflation)
makes the insertion and radiography easier and more convenient.
* Three different sizes for each balloon, meets demands of different patients.
* Equipped with Radiopaque marks on both ends of balloon, convenient for locating under X-ray.
* Unique design of tapering catheter, improves the insertion into palilla.


3. Specifications:

Model	Balloon Diameter (mm)	Catheter Diameter (mm)	Working Length (mm)	Lumen No.
JHY-BAL-23-8.5/11.5/15-B	8.5/11.51/15	2.3	2000	3
JHY-BAL-23-9/12/15-B	9/12/15	2.3	2000	3
JHY-BAL-23-11/13/15-B	11/13/15	2.3	2000	3
JHY-BAL-23-10/13/16-B	10/13/16	2.3	2000	3

4.  Materials
 

Component	Material	Standard
Balloon	NR	ISO 1658-2009
Catheter	Pebax	ISO 1874-2010
Handle	ABS	ISO 2580-2-2003
Standard connector	PC	ISO7391-1-2006

5. Product Packaging:
1) Inner Packaging: The inner package is PE+ Dupont paper.
2) Middle Package: The middle package is 3-layer corrugated paper.
3) Outer Package: The outer package is 5-layer corrugated paper.