735019

Organization name

Laboratorios Grifols S.A.

SRN

ES-MF-000000767

Manufacturer status

Active

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

• CW999

  - Do not use if the individual package is not intact or if the protective caps are damaged or missing. - Do not use if the packaging is damaged or presents visible signs of damage. - The sterile barrier system is the individual package. - Once the individual package is opened, the product must be used immediately. - Use immediately after removing the protective caps. - Do not use the product if the expiry date has been exceeded (see expiry date indicated in the container). - Single use product. Do not reuse. Device reuse poses risk of infection. To avoid cross contamination, change the set when source solution is changed. Replace the set at least every 24 hours. - Refer to the Instructions for use section for the step by step procedure for the use of the device. - This device is NOT intended for direct patient connection. - Check the compatibility with drugs before use. - In case of using glass or rigid plastic containers, make sure to keep the air entrance opened throughout the process. - Pay attention to the warning messages displayed on the screen of the Gri-fill dispenser.

Primary placement in Spain; available across 3 countries total.

Trade name

not provided

UDI-DI code

08437017294016

Basic UDI-DI

8437017294A070003NB

Reference / catalog number

735019

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

Gri-fill Peristaltic Set is a sterile and non-pyrogenic disposable set for use in conjunction with the Gri-fill Pharmacy Compounder and the Gri-fill 2 Ways Set. It consists of a silicone tube connected at one end to a male luer-lock connector and a spike (with a 1.2 μm hydrophobic air filter) for the connection of the set to the source container, and at the other end to a female luer-lock connection that joins the set with the Gri-fill 2 Ways Set. The silicone tube allows the set to be used with a peristaltic pump. Gri-fill Peristaltic Set is supplied sterile in individual sealed peel-pack pouches.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• A0704SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS

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