Sodium Chloride
Sodium Chloride
LABORATORIOS GRIFOLS, S.A.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3002807257 | 3002807257 | LABORATORIOS GRIFOLS, S.A. | 1 | N | 2026-01-01 | POL. LEVANTE C/CAN GUASCH, 2 PARETS DEL VALLES Barcelona ES 08150 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 61864 | 2044652230 | K162216 | GRI-FILL PERISTALTIC SET | LHI | 2017-10-19 |
| 61864 | 1454198557 | K102590 | FLEBOSET DOUBLE | LHI | 2011-01-13 |
| 61864 | 1153869991 | K093182 | SET GRI-FILL 3.0 | LHI | 2010-01-27 |
| 61864 | 1118166238 | K082752 | QUICKPIN | LHI | 2008-09-29 |
| 61864 | 1934258549 | K050339 | SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE | LHI | 2005-02-25 |
| 61864 | 1019124957 | K040456 | FLEBOSET MULTIPLE | LHI | 2004-03-09 |
| 61864 | 1518179003 | K033916 | GRI-BAG, GRI-BAG AP | KPE | 2003-12-30 |
| 61864 | 1892209812 | K031419 | GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML | KPE | 2003-11-24 |
| 61864 | 1530172625 |
Product Codes Associated With Registrations#
NDC#
Anticoagulant Sodium Citrate
Trisodium Citrate Dihydrate
PMN#
GRI-FILL PERISTALTIC SET
LABORATORIOS GRIFOLS, S.A.
FLEBOSET DOUBLE
LABORATORIOS GRIFOLS, S.A.
SET GRI-FILL 3.0
LABORATORIOS GRIFOLS, S.A.
QUICKPIN
LABORATORIOS GRIFOLS, S.A.
SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE
LABORATORIOS GRIFOLS, S.A.
FLEBOSET MULTIPLE
LABORATORIOS GRIFOLS, S.A.
GRI-BAG, GRI-BAG AP
LABORATORIOS GRIFOLS, S.A.
SET GRI-FILL 2.0-1 WAY; 2.0-2 WAYS; LUER CONNECTION TUBE
LABORATORIOS GRIFOLS, S.A.
GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML
LABORATORIOS GRIFOLS, S.A.
Applications#
GUDID#
GRI-FILL 2 Ways Set - Gri-fill 2 Ways Set is a fluid transfer set for use with the Gri-fill 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. Gri-fill 2 Ways Set is made up of a syringe, a distributor, tubing to channel the fluid and a waste/residue bag. Set is available for 1 or 2 source substances. Also a Luer female - female adapter is available as an accessory to the Gri-fill 2 Ways Set.
2022-03-15
GRI-FILL - GRI-FILL is a pharmacy compounding device (PCD) and as such is an electromechanical device controlled by software intended to deliver a specified concentration or proportion of ingredients different from the initial solutions.
2023-07-19
GRI-FILL PERISTALTIC SET - Gri-fill Peristaltic Set is an IV fluid transfer set to be used in conjunction with the Gri-Fill Pharmacy Compounder and ancillary Gri-Fill sets in hospital pharmacy to provide a fluid pathway through which one source substance is channeled repeatedly to an IV container. It consists of a silicone tube linking a male luer-lock connector and a spike (with a 0.2 µm hydrophobic air filter), and a female luer-lock connection.
2018-11-21
GRI-FILL 6 to1 Set - 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.
2021-10-25
GRI-BAG - 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.
2021-10-26
GRI-BAG - 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.
2021-10-26
GRI-BAG - 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.
2021-10-26
GRI-BAG - 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..
2021-10-26
FLEBOSET - FLEBOSET DOUBLE is a disposable transfer set through which substances form 2 different vials containing the same solution may be continuously delivered for: a) IV administration when used in conjunction with a gravity or pump infusion set, with luer-lock connection to the drip chamber, to cannel the solution from the source vials to the infusion set, and b) Pharmacy compounding when used in conjuntion with the Grifill pharmacy compounding device and associated transfers sets. Equipped with a spike on each line and a 0.2um hydrophobic air-filter, it minimizes teh formation of aerosols when preparing/dispensing the source substances.
2017-04-05
QUICKPIN - 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.
2017-04-05
SET GRI-FILL 3.0 - 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.
2017-01-02
QUICKPIN - 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.
2017-04-05
GRI-BAG - 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.
2021-10-26
GRI-BAG - 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.
2021-10-26
GRI-BAG - 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.
2021-10-26
GRI-BAG - 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..
2021-10-26
GRI-FILL 6 to1 Set - 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.
2021-10-25
GRI-BAG - 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.
2017-04-05
GRI-BAG - 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.
2017-04-05
GRI-BAG - 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.
2017-04-05
GRI-BAG - 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.
2017-01-02
GRI-BAG - 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.
2017-04-05
GRI-BAG - 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.
2017-04-05
SET GRI-FILL 3.0 - 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.
2017-01-02
SET GRI-FILL 3.0 - 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.
2017-01-02
FLEBOSET - 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.
2017-04-05
GRI-BAG - 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.
2017-04-05
GRI-BAG - 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.
2017-04-05
FLEBOSET - FLEBOSET DOUBLE is a disposable transfer set through which substances form 2 different vials containing the same solution may be continuously delivered for: a) IV administration when used in conjunction with a gravity or pump infusion set, with luer-lock connection to the drip chamber, to cannel the solution from the source vials to the infusion set, and b) Pharmacy compounding when used in conjuntion with the Grifill pharmacy compounding device and associated transfers sets. Equipped with a spike on each line and a 0.2um hydrophobic air-filter, it minimizes teh formation of aerosols when preparing/dispensing the source substances.
2017-04-05
SET GRI-FILL 3.0 - 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.
2017-01-02
SET GRI-FILL 3.0 - 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.
2017-01-02
SET GRI-FILL 3.0 - 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.
2017-01-02
FLEBOSET - 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.
2017-04-05
GRI-BAG - 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.
2017-04-05
GRI-BAG - 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.
2017-04-05
GRI-BAG - 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.
2017-04-05
GRI-BAG - 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.
2017-01-02