735204

Organization name

Laboratorios Grifols S.A.

SRN

ES-MF-000000767

Manufacturer status

Active

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• 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 individual package). - Single use product. Do not re-use. The product reuse poses risk of infection. To avoid cross contamination, change the set when source solutions are changed. Replace the set at least every 24 hours. - Do NOT connect the product directly to the patient. - Use the Gri-fill 6 to 1 Set only with one source solution type. - Check the compatibility with drugs before use. - Pay attention to the warning messages displayed on the screen of the Gri-fill Pharmacy Compounder.

Primary placement in EL; available across 1 country total.

Trade name

not provided

UDI-DI code

08437017294061

Basic UDI-DI

8437017294A070002N9

Reference / catalog number

735204

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 6 to 1 Set is a single-use, sterile non-pyrogenic fluid transfer set used in conjunction with the Gri-fill 2 Ways Set through which the same substance from up to 6 rubber-stoppered glass vials is channeled to a final container. The principal components of the Gri-fill 6 to 1 Set are 6 mini-spikes (one of them incorporates a 0.2-micron hydrophobic air filter that minimizes the formation of aerosols when preparing and dispensing the source substances) and PVC tubing linking the mini-spikes. The spike on each line facilitates easy puncture of thick rubber stoppers of small diameter. The device provides fast fluid addition and extraction due to the large surface area of the air-filter that quickly equalizes pressures. It 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

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• Manufacturing date
• Serial number
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