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Organization name
UDI-DI code
Reference / catalog number

735258 — Class I MDR by Laboratorios Grifols S.A.

MD Atlas
Laboratorios Grifols S.A.

EUDAMED last updated this device on Sep 5, 2025

735258

8437017294A080001NJ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Laboratorios Grifols S.A.
UDI-DI code: 18437017294549
Reference / catalog number: 735258

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Manufacturer information

Organization name: Laboratorios Grifols S.A.
SRN: ES-MF-000000767
Manufacturer status: Active

Critical warnings

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

CW999
- Do not use if the peel-pack pouch is not intact. - Do not use if the packaging is damaged or presents visible signs of damage. - The sterile barrier system is the peel-pack pouch. - Once the peel-pack pouch is opened, the product must be used immediately. - The maximum pressure of use of the bag during the dosing process is 4 bars. - Use aseptic technique. - Do not use plastic containers in series connections. - Do not use the product if the expiry date has been exceeded (see expiry date indicated in the package). - Single use product. Do not re-use. The product reuse poses risk of infection. - Check the compatibility with drugs before use. - Use only with solutions that are compatible with each other. - Store filled containers in conditions suitable for the added solutions. - Pay attention to the warning messages displayed on the screen of the Gri-fill Pharmacy Compounder.

Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement	Jul 30, 2025	Still on market
Portugal	Aug 5, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 18437017294549
Basic UDI-DI: 8437017294A080001NJ
Reference / catalog number: 735258
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 5
Additional product description: Gri-Bag is a single-use, sterile, non-pyrogenic and flexible empty container with incorporated 0.2 µm filter. It is supplied sterile in 5-unit sealed peel-pack pouches and is available in volume capacities of 100 mL, 250 mL, 500 mL and 1000 mL. The Gri-Bag has a twist-off valve output connector.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A080299INFUSION BAGS AND CONTAINERS, SINGLE-USE - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

1.5% Glycine GrifolsB-ESMF000000767725176V8On the market 725060B-ESMF000000767725060ULOn the market Bags for Gri-fill System: Gri-Bag8437017294A080001NJOn the market Bags for Gri-fill System: Gri-Bag8437017294A080001NJOn the market Bags for Gri-fill System: Gri-Bag8437017294A080001NJOn the market

Certificates

Certificate health across this manufacturer's portfolio.

2023 CR 0002Issued
Quality management systemNotified body: 0318Expiry: May 31, 2028
2023 CR 0002Issued
Quality management systemNotified body: 0318Expiry: May 31, 2028