DOUBLEFLO Day Tube Set

Organization name

HEMODIA SAS

SRN

FR-MF-000007191

Manufacturer status

Active

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

• CW007

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

  EUDAMED did not publish a description for this code.
• CW020

  EUDAMED did not publish a description for this code.
• CW999

  Only use with a Patient Tube Set with check valve (REF. 72205773, REF. 72205354).
• CW999

  Replace the tubing in case of malfunction or variation in performance.
• CW999

  Be careful when inserting or removing the blue connector: do not insert nor remove the blue connector with pressure inside to avoid to deform the white silicone membranes of the pressure sensors of the pump.
• CW999

  For clinical benefits, complications and precautions to be taken during the arthroscopy procedure, refer to and read the DOUBLEFLO Pump instruction manual (REF. 104785, REF. 105074)
• CW999

  Sterility is preserved only if proper setup and tube changing procedures have been followed according to the DOUBLEFLO Pump instruction manual (REF. 104785, REF. 105074).

Primary placement in France; available across 10 countries total.

Trade name

DOUBLEFLO Day Tube Set

UDI-DI code

03661379223055

Basic UDI-DI

3661379FAB020002AEF

Reference / catalog number

72205772

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

An arthroscopy tubing is intended to conduct fluid to irrigate and clean a joint during minimally invasive arthroscopic procedures. The Day tube set is intended for one day use (up to 14 hours of use) and delivers 0.9% saline solution (irrigation fluid) from a fluid bag to the patient tube set.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• A0399TUBULAR DEVICES - OTHER

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