HSA · registration DE0018068Aesculap Flow40 Insufflator
- Registration number
- DE0018068
- Model name
- VERESS INSUFFLATION NEEDLE 10CM; VERESS INSUFFLATION NEEDLE 12CM; VERESS INSUFFLATION NEEDLE 15CM; SILICONE TUBE NO GAS PREHEAT; FLOW40 INSUFFLATOR; INSUFFLATION TUBE W/GAS PREHEATING; NIST CONNECTOR F/FLOW40; HIGH-PRESS.TUBE.CENTR.SPLY NIST/DIN 3MM; HIGH-PRESS.TUBE.CENTR.SPLY NIST/DIN 5M; HIGH PRESSURE TUBE 1M US/DIN; HIGH PRESSURE TUBE 1M US/ISO; HIGH PRESSURE TUBE 1M US/PIN; FLOW40 INSUFFLATOR W/INTERFACE TEGRIS
- Model identifier
- PG003; PG008; PG011; PG014; PG080; PG082; PG083; PG084; PG085; PG086; PG087; PG088; PG200
- Registration date
- April 29, 2016
- Risk class
- Class C
- Product owner
- AESCULAP AG
- Registrant / registration holder
- B. BRAUN SINGAPORE PTE. LTD.
The insufflator PG080/PG200 is an active medical device and is used for therapeutic and diagnostic procedures in the field of laparoscopy. For this purpose, the peritoneum is insufflated with CO2 and dilated using a trocar or Veress needle. In addition, the insufflator is used to create an CO2 environment during open or endoscopic cardiac surgeries. The CO2 environment reduces the risk of air embolism and thus the occurrence of cardiovascular and cerebral insults. In cardiac surgery, CO2 insufflation is not used to dilate blood vessels and organs. CO2 is used to improve the visibility in coronary bypass anastomosis procedures. CO2 is transported by means of a sterile tube set.
- Product owner address
- Am Aesculap-Platz, 78532 Tuttlingen, Germany
- Registrant address
- 18 NEPAL PARK, #02-02, Singapore 139407
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.