BIP Foley Catheter 2-way, 30 Ch/Fr, 30ml/cc

Trade name

BIP Foley Catheter 2-way, 30 Ch/Fr, 30ml/cc

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

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07333330104906

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

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7333330FOLEYLATUV110301Z9

Reference / catalog number

111303010

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

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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 is sterile, single use, disposable urethral catheter of Foley type. The BIP Foley Catheter is made of natural rubber latex that is coated with the Bactiguard® coating and hydrophilic coating. The Bactiguard® coating consists of an alloy of noble metals that reduces adhesion and colonization of microorganisms (e.g. bacteria) on the surface of the catheter. The hydrophilic coating offers excellent lubrication for improved patient comfort during use. The BIP Foley Catheter has good tissue friendliness.

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

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  Allergy or sensitivity to latex
• 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)  Allergy or sensitivity to latex