116163010

Organization name

Bactiguard AB

SRN

SE-MF-000020790

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW999

  Under the following conditions the use of the device should be avoided, unless justified by the treating physician: For urethral catheterization: ● Trauma of urethra or bladder ● Acute prostatitis
• CW999

  Under the following conditions the use of the device should be avoided, unless justified by the treating physician: For suprapubic catheterization: ● Known or suspected carcinoma of the bladder ● Absence of an easily palpable or ultrasonographically localized distended urinary bladder ● Previous lower abdominal surgery ● Coagulopathy (until the abnormality is corrected) ● Ascites ● Prosthetic devices in lower abdomen (e.g., hernia mesh)

Primary placement in Sweden; available across 1 country total.

Trade name

not provided

UDI-DI code

07333330104050

Basic UDI-DI

7333330FOLEYSIL120101ZR

Reference / catalog number

116163010

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

The BIP Foley Catheter - Silicone are silicone Foley catheters. The catheter body has the benefit of the Bactiguard® coating, applied both on the inside and the outside. The coating consists of a noble metal alloy that reduces microbial adhesion to the catheter surface. To increase patient comfort, the catheter also has a hydrophilic coating that provide excellent lubrication. The BIP Foley Catheter -Silicone is tissue friendly.

Additional information URL

https://www.bactiguard.com/

Clinical sizes

No clinical sizes registered for this device.

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

• U010299URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER

Certificate health across this manufacturer's portfolio.