Redsense Clamp System

Trade name

Redsense Clamp System

UDI-DI code

07350078030373

Basic UDI-DI

7350078030373X2

Reference / catalog number

RB-1-RB201

Issuing entity

GS1

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The Redsense Clamp is a wireless device that communicates with the Redsense Alarm to reduce external blood loss until appropriate corrective action can be taken by the user, if a venous needle dislodgement / access-bloodline separation occurs during hemodialysis. The wireless Clamp System works in tandem with the Redsense Alarm as a Blood Loss Security System, safeguarding the venous access with real-time monitoring, detection, and mitigation of blood loss.

Additional information URL

https://redsensemedical.com/products/clamp/

Clinical sizes

• 100 g (for Redsense Bloodline Clamp) and 50 g (for Redsense Dongle)
• 130 x 65 x 34 mm (for Redsense Bloodline Clamp) and 88 x 43 x 31 mm (for Redsense Dongle)

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

• F9099DIALYSIS DEVICES - OTHER

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• CW010

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• CW022

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• CW007

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• CW027

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• CW134

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• CW135

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• CW136

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• CW138

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• CW018

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• CW030

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