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Stryker PNEUMOCLEAR™ - HSA Registration DE0502141

Access comprehensive regulatory information for Stryker PNEUMOCLEAR™ in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0502141 and owned by Stryker Endoscopy. The device was registered on September 11, 2018.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0502141
Stryker PNEUMOCLEAR™
HSA Registration Number: DE0502141
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Product Description

The device PNEUMOCLEAR™ is a CO2- insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with CO2 gas. The operating modes Standard, High Flow/Bariatric, Pediatric and Advanced Flow of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is indicated for pediatric laparoscopic procedures. The Vessel Harvest operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery. The TAMIS operating mode is indicated to fill and distend the rectum and colon using CO2 gas during transanal minimally invasive surgery

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0502141
Registration Date
September 11, 2018
Change Notification Approval Date
March 20, 2025
Retention Due Date
September 10, 2025
Product Owner
Short Name
Stryker
Address
5900 Optical Court, San Jose, CA 95138, UNITED STATES
Registrant
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Importer
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Model Information
Model Name(s)
PNEUMOCLEAR CO2 Conditioning Insufflator PNEUMOCLEAR CO2 Conditioning Insufflator PNEUMOCLEAR CO2 Conditioning Insufflator PNEUMOCLEAR CO2 Conditioning Insufflator PNEUMOCLEAR HIGH-FLOW TUBE SET PNEUMOCLEAR HEATED HIGH-FLOW TUBE SET PNEUMOCLEAR SMOKE EVACUATION HIGH-FLOW TUBE SET PNEUMOCLEAR HEATED HUMIDIFIED TUBE SET PNEUMOCLEAR HEATED HUMIDIFIED SMOKE EVACUATION TUBE SET Hose for CO2 gas bottle DIN:US, 1.5 m / 4.92 ft Hose for CO2 gas bottle ISO:US, 1.5 m / 4.92 ft Hose for CO2 central gas DIN:US, 3 m / 9.8 ft Hose for CO2 central gas DIN:US, 5 m / 16.4 ft Hose for CO2 central gas AGA:US, 3 m / 9.8 ft Hose for CO2 central gas AGA:US, 5 m / 16.4 ft Hose for CO2 central gas NF:US, 3 m / 9.8 ft Hose for CO2 central gas NF:US, 5 m / 16.4 ft Hose for CO2 central gas UNI:US, 3 m / 9.8 ft Hose for CO2 central gas UNI:US, 5 m / 16.4 ft NIST Adapter for universal gas connection DISS Adapter for universal gas connection US Adapter for universal gas connection Universal gas connector CO2, angled
Model Identifier(s)
0620050000 0620050010 0620050050 0620050060 0620050100 0620050200 0620050250 0620050300 0620050350 0620050900 0620050901 0620050904 0620050905 0620050906 0620050907 0620050908 0620050909 0620050910 0620050911 0620050912 0620050913 0620050914 0620050915