LABORATORIOS GRIFOLS SA

Address:POL. LEVANTE C/CAN GUASCH, 2,PARETS DEL VALLES Barcelona,ES

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Device Description : GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporate GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filter. It is supplied sterile in sealed peel-pack pouches and isavailable in volume capacities of 100 ml, 250 ml, 500 ml and 1000 ml. The GRI-BAG models have a twist-off valve output connector whereas the GRIBAGAP models have a conus vial output connector.

Device Class :

Duns Number: 463720681

Premarket Exempt : No

Product Code : KPE, FPB, NEP

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporate GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filter. It is supplied sterile in sealed peel-pack pouches and is available in volume capacities of 100 ml, 250 ml, 500 ml and 1000 ml. The GRI-BAG models have a twist-off valve output connector whereas the GRIBAG AP models have a conus vial output connector.

Device Class : 2

Duns Number: 463720681

Premarket Exempt : No

Product Code : FPB, NEP, KPE

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : FLEBOSET MULTIPLE is a fluid transfer tubing set used to enable continuous (unin FLEBOSET MULTIPLE is a fluid transfer tubing set used to enable continuous (uninterrupted) delivery of drug solutions from 6 glass source containers. It is used in pharmacy compounding or for IV fluid transfer to minimize manipulation when working with small volumen source containers. The device is made up of 6 spikes connected in series with flexible tubing segments, each segment with an idividual clamp. The set terminal, for connection to the pharmacy compounding device sets or administration sets (gravity or pump) consists of a spikeable twist-off valve connector.

Device Class : 2

Duns Number: 463720681

Premarket Exempt : No

Product Code : LHI, FPK

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : SETS GRI-FILL 3.0 are fluid transfer sets for use with the GRI-FILL 3.0 pharmacy SETS GRI-FILL 3.0 are fluid transfer sets for use with the GRI-FILL 3.0 pharmacy compounding device in order to compound or mix different multi-ingredient solutions and to channel them into a final suitable IV container. The set is a disposable component of the compounding device. The 1 WAY / 2 WAY models are made up of a syringe, a distributor, tubing to channel the fluid and a waste/residue bag. Sets are available for 1 or 2 source substances. Also a Luer female - female adapter is available as an accessory to the 1 or 2 way transfer sets. The MULTIPLE model is also used as an accessory with the 1IWAY I 2WAY sets for channeling the same solution from up to six (6) source containers delivering them into a final IV container. It is made up of connectors and tubing to enable interconnection of the different source containers.

Device Class : 2

Duns Number: 463720681

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : SETS GRI-FILL 3.0 are fluid transfer sets for use with the GRI-FILL 3.0 pharmacy SETS GRI-FILL 3.0 are fluid transfer sets for use with the GRI-FILL 3.0 pharmacy compounding device in order to compound or mix different multi-ingredient solutions and to channel them into a final suitable IV container. The set is a disposable component of the compounding device. The 1 WAY / 2 WAY models are made up of a syringe, a distributor, tubing to channel the fluid and a waste/residue bag. Sets are available for 1 or 2 source substances. Also a Luer female - female adapter is available as an accessory to the 1 or 2 way transfer sets. The MULTIPLE model is also used as an accessory with the 1IWAY I 2WAY sets for channeling the same solution from up to six (6) source containers delivering them into a final IV container. It is made up of connectors and tubing to enable interconnection of the different source containers.

Device Class : 2

Duns Number: 463720681

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : SETS GRI-FILL 3.0 are fluid transfer sets for use with the GRI-FILL 3.0 pharmacy SETS GRI-FILL 3.0 are fluid transfer sets for use with the GRI-FILL 3.0 pharmacy compounding device in order to compound or mix different multi-ingredient solutions and to channel them into a final suitable IV container. The set is a disposable component of the compounding device. The 1 WAY / 2 WAY models are made up of a syringe, a distributor, tubing to channel the fluid and a waste/residue bag. Sets are available for 1 or 2 source substances. Also a Luer female - female adapter is available as an accessory to the I or 2 way transfer sets. The MULTIPLE model is also used as an accessory with the 1IWAY I 2WAY sets for channeling the same solution from up to six (6) source containers delivering them into a final IV container. It is made up of connectors and tubing to enable interconnection of the different source containers.

Device Class : 2

Duns Number: 463720681

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporate GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filter. It is supplied sterile in sealed peel-pack pouches and isavailable in volume capacities of 100 ml, 250 ml, 500 ml and 1000 ml. The GRI-BAG models have a twist-off valve output connector whereas the GRIBAGAP models have a conus vial output connector.

Device Class :

Duns Number: 463720681

Premarket Exempt : No

Product Code : KPE, FPB, NEP

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporate GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filter. It is supplied sterile in sealed peel-pack pouches and isavailable in volume capacities of 100 ml, 250 ml, 500 ml and 1000 ml. The GRI-BAG models have a twist-off valve output connector whereas the GRIBAGAP models have a conus vial output connector.

Device Class : 2

Duns Number: 463720681

Premarket Exempt : No

Product Code : FPB, KPE, NEP

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : QUICKPIN is a luer-lock spike used in manual or automated pharmacy compounding f QUICKPIN is a luer-lock spike used in manual or automated pharmacy compounding for addition and/or extraction of IV substances from rubber stoppered containers including multi-dose vials.

Device Class : 2

Duns Number: 463720681

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : Fluid transfer set consisting of PVC tubing linking 6 mini-spikes to be used in Fluid transfer set consisting of PVC tubing linking 6 mini-spikes to be used in conjunction with 2 ways transfer set through which the same substance from up to 6 rubber-stoppered glass vials may be delivered into a final IV container. It is equipped with a 0.2 micron hydrophobic air-filter that minimizes the formation of aerosols when preparing and dispensing the source substances. 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.

Device Class : 2

Duns Number: 463720681

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1