Redsense Venous Sensor Patch

Organization name

Redsense Medical AB

SRN

SE-MF-000005240

Manufacturer status

Active

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

• CW196

  Remove sensor from skin. Rinse with water if necessary.
• CW010

  EUDAMED did not publish a description for this code.
• CW030

  EUDAMED did not publish a description for this code.
• CW022

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW134

  EUDAMED did not publish a description for this code.
• CW135

  EUDAMED did not publish a description for this code.
• CW136

  EUDAMED did not publish a description for this code.
• CW018

  EUDAMED did not publish a description for this code.

Primary placement in Spain; available across 10 countries total.

Trade name

Redsense Venous Sensor Patch

UDI-DI code

07350078030328

Basic UDI-DI

7350078030328WV

Reference / catalog number

RS-1-RS201-S

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 venous sensor patch is a non invasive patch that consists of an optic fiber and an absorbent sponge-like material. The patch should be applied directly on the venous access point with the absorbent part of the patch placed over the needle.

Additional information URL

https://redsensemedical.com/training-education/instruction-guides/

Clinical sizes

• < 5 grams
• 150 x 62 x 1 mm

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• F9099DIALYSIS DEVICES - OTHER