# K033916: Gri-Bag, Gri-Bag AP

- Pathway: 510(k) (Traditional)
- Applicant: Laboratorios Grifols, S.A.
- Decided: Dec 30, 2003 after 12 days
- Product code: KPE (Container, I.V.)
- Device class: 2
- Regulation: 21 CFR 880.5025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Viaflex Plastic Container (Baxter): named in the summary without a submission number
- (no number) Pall Supor Aef: named in the summary without a submission number

## Recalls of this device
- Nov 29, 2005 · Not classified · Z-0906-06: When the bags are filled with solution, they leak. The labeling process caused a hole to be formed in the bag.

## Indications for use
All models of GRI-BAG are flexible I.V. bags, with incorporated 0.2 gm filter for the removal of undesired particulate or microbial matter, for use with the GRI-FILL pharmacy compounding system as a container in the preparation of drug solutions. The drug solution is later administered to the patient by connecting the bag to an I.V. administration set. This device is intended to be used by trained health care personnel. It is restricted to sale by or on order of a physician. The device should not be used with lipids.

Source page: https://510kreport.com/device/K033916
Methodology: https://510kreport.com/methodology