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Gri-Flex (1000ml +3 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K031419

by Laboratorios Grifols, S.a.

Identifiers

510(k) Number
K031419 FDA 510(k)
FDA Product Code
KPE FDA 510(k)
Models / Variants
1000ml FDA 510(k)
500ml FDA 510(k)
250ml FDA 510(k)
100ml FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5025 FDA 510(k)
Regulation Number
880.5025 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

GRI-FLEX is a single-use, sterile, flexible I.V. container with an integrated 0.2 µm polyethersulphone filter. It is used in pharmacy settings with the GRI-FILL system for drug solution preparation and acts as a container for drug admixtures.

The device is supplied sterile in sealed peel-pack pouches and is available in volume capacities of 100 ml, 250 ml, 500 ml and 1000 ml. It has received FDA 510(k clearance with the decision code SESE, indicating it is substantially equivalent.

Frequently asked questions

What is the GRI-FLEX I.V. container used for?

GRI-FLEX is a single-use sterile flexible I.V. container with an integrated 0.2 µm polyethersulphone filter. It is used in pharmacy settings with the GRI-FILL system for drug solution preparation and acts as a container for drug admixtures.

How is the GRI-FLEX I.V. container supplied?

The device is supplied sterile in sealed peel-pack pouches and is available in volume capacities of 100 ml, 250 ml, 500 ml and 1000 ml. It is designed for single-use only and should not be reused.

What regulatory approvals does the GRI-FLEX I.V. container have?

GRI-FLEX has received FDA 510(k) clearance with the decision code SESE, indicating it is substantially equivalent. It is classified as a Class 2 device and is intended for use in general hospital settings.

What are the available sizes of the GRI-FLEX I.V. container?

The GRI-FLEX I.V. container is available in four volume capacities: 100 ml, 250 ml, 500 ml, and 1000 ml, allowing flexibility for different medication preparation needs in pharmacy settings.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Gri-flex, Models 1000ml, 500ml, 250ml, 100ml, 510(k) Premarket Notification - accessdata.fda.gov, LABORATORIOS GRIFOLS, S.A. FDA Filings - FDA.report, LABORATORIOS GRIFOLS SA 100 GRI-BAG - RevMed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Laboratorios Grifols, S.a.

Sources (1)

  • FDA 510(k) K031419 24 fields · synced Sep 27, 2026