AVFN16GR/15

Organization name

Allmed Medical GmbH

SRN

DE-MF-000007862

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  Contraindications: Patients unsuitable for conventional fistula (The use of fistula needle and puncturing a vessel or a graft is in itself not a therapeutic procedure .there are contraindications apart from risks generally associated with punctures by large bore needles in conjunction with extracorporeal blood circuits or due known or suspected allergies against the materials used in the product. However, contraindications may be inherent in the procedures requiring the access to the blood. Therefore; the use of this device is restricted to an order by a physician and should be used following the physician’s instructions). Patients where anticipated blood flow is inadequate. Patients with sensitivity to ETO should not be exposed to Allmed Fistula Needle. Avoid use of Fistula Needles and constituent materials in patients with known hypersensitivity.

Primary placement in Germany; available across 1 country total.

Trade name

not provided

UDI-DI code

04260157724891

Basic UDI-DI

426015772FNEEDLEEO2K

Reference / catalog number

AVFN16GR/15

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

Fistula Needle is intended to be used during dialysis treatment. It is a part of accessory of extracorporeal system for treatment of patients suffering from acute\chronic renal failure. Fistula Needle is applied on the access site of patient’s vessel to obtain blood flow adequate to pass through the dialyzer, and the reinfusion of dialysed blood back to patient via fistula needle. The device is intended to be used for adult only, the device life time is 6 hours “maximum operating time. It is a sterile, sharp bevel-edged, hollow tubular metal instrument used to remove and return a patient's blood during a hemodialysis procedure. Arterial Venous Fistula Needle Ethylene oxide (EO) sterilized, rotating wings, 15 cm tube length

Additional information URL

https://allmedgroup.com/e-ifu-repository/

Clinical sizes

• 16

• A010499DIALYSIS NEEDLES - OTHER

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