LimFlow Stent Graft System

Organization name

LimFlow SA

SRN

FR-MF-000011529

Manufacturer status

Active

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

• CW999

  The use of the device should be limited to those specialists trained to perform the procedures for which this device isintended.
• CW999

  The device should not be used without first reading and understanding these directions in their entirety.
• CW999

  The Stent Graft System is designed and intended forsingle use only. Do not autoclave, reshape, re-sterilize or reuse. Exposure to high heat may cause changes to the functionality of the device. Reuse, even if re-sterilized, can compromise the Stent Graft System performance characteristics and may cause infection.
• CW999

  Do not use organic solvents (e.g. alcohol) with the delivery system.
• CW999

  Use in patients with concomitant hepatic insufficiency has not been evaluated.
• CW999

  Use inpregnant and breastfeeding women has not been evaluated.
• CW999

  Long-term outcomes in patients with renal insufficiency have not been evaluated.
• CW999

  Contraindicated in patients with deep venous thrombus in target vein.
• CW999

  Contraindicated in patients with uncorrected bleeding disorders or patients who cannot receive anticoagulation or antiplatelet aggregation therapy.
• CW999

  Contraindicated in patients with a poor cardiac output, because an AV fistula may increase the risk for cardiac decompensation.
• CW999

  Contraindicated in neonate and pediatric patients.
• CW999

  MRI Conditional

Primary placement in Germany; available across 5 countries total.

Trade name

LimFlow Stent Graft System

UDI-DI code

00850017630406

Basic UDI-DI

0850017630SGXDDLLLCE21XB

Reference / catalog number

SGH-55060-CE-21

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

Stent Graft 5.5 x 60 with Handle mechanism

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 5.5 mm
• 60 mm

• P0704020299PERIPHERAL VASCULAR STENTS - OTHER

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

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