All Silicone Foley Catheter with Temperature Sensor

Trade name

All Silicone Foley Catheter with Temperature Sensor

UDI-DI code

06944932785663

Basic UDI-DI

69449327FF01C00E9

Reference / catalog number

F01C010804

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

All Silicone Foley Catheter with Temperature Sensor enables clinicians to accurately monitor urinary output and bladder temperature in addition to facilitating urine drainage. Commonly used to monitor a patient’s core body temperature during open-heart surgery. The method of urinary bladder temperatures monitoring has been used routinely intraoperative and postoperative continuous use in adult patients since the method was found as good as pulmonary arterial blood temperature monitoring. All Silicone Foley Catheter with Temperature Sensor product is composed of Foley Catheter with Temperature Sensor, Pre-loaded stylet (if any) and Cap (if any). Foley Catheter with Temperature Sensor is made from silicone, consists of temperature sensor, shaft, funnels, balloon, valve, tip or elbow.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 2-way Pediatric 8Fr 5mL

European Medical Device Nomenclature — the EU product classification assigned to this device.

• U0103URETHRAL PROSTATIC AND BLADDER CATHETERS WITH TEMPERATURE SENSORS

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  1.Acute urethritis;2.Acute prostatitis; 3.Acute epididymitis; 4.Allergy to latex; 5.Urethral injury or urethrostenosis; 6.Menstrual period

No certificate specifically references this device's Basic UDI-DI.