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Sources: EU EUDAMED, US FDA
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PNEUMOCLEAR Heated High-Flow Tube Set Product Usage: The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the PNEUMOCLEAR C02 insufflator as a separate accessory. The device PNEUMOCLEAR is a C02 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, High Flow/Bariatric, Pediatric and Advanced Flow operating mode 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 C02 gas during trans anal minimal invasive surgery.
FDA Enforcement
Class II
·Terminated·WOM World of Medicine AG·December 5, 2018
Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
FDA Enforcement
Class II
·Terminated·WOM World of Medicine AG·October 9, 2019
Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Models AQL-100PBS and AQL-100P
FDA Enforcement
Class II
·Ongoing·WOM World Of Medicine AG·October 4, 2023
Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
FDA Enforcement
Class II
·Ongoing·WOM World of Medicine AG·October 6, 2021
MDD-072
Certificate
MDD Annex II (excluding section 4)·adeor medical AG·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ·7 Basic UDI-DIs
MDR-0019
Certificate
MDR QMS·newbox medical GmbH·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ
MDR-0018
Certificate
MDR QMS·adeor medical AG·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ
MDR-002
Certificate
MDR QMS·Kirchner & Wilhelm GmbH + Co KG·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ
Promedia A. Ahnfeldt GmbH
Importer
🇩🇪 Germany·7 Manufacturers
TapMed Medizintechnik Handels GmbH
Importer
🇩🇪 Germany·10 Manufacturers
TapMed Logistik GmbH
Importer
🇩🇪 Germany·11 Manufacturers
PENTAX Europe GmbH
Importer
🇩🇪 Germany·9 Manufacturers
DE/CA97, Federal Ministry of Defence, Forces Policy Medical 3
Competent authorityGermany
0 Manufacturers
0 Basic UDI-DIs
0 Devices