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510(k) Data Aggregation
K Number
K162216Device Name
GRI-FILL PERISTALTIC SET
Manufacturer
LABORATORIOS GRIFOLS, S.A.
Date Cleared
2017-10-19
(437 days)
Product Code
LHI, REG
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
LABORATORIOS GRIFOLS, S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Gri-Fill Peristaltic Set fluid transfer set is an ancillary device 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 solution source is delivered into a final IV container. This device is not intended to be directly connected to the patient.
Device Description
Gri-fill Peristaltic Set is a disposable fluid transfer set for connection to a source container and to Gri-fill sets for use with the Gri-Fill Pharmacy Compounder. lt consists of a silicone tube linking a male luer-lock connector and a spike (with a 1.2 um hydrophobic air filter) for connecting to the source container, and a female luer-lock connection, for connecting to the Gri-fill set. The silicone tube allows the set to be used with a peristaltic pump. The Gri-fill Peristaltic Set is intended to be used by trained health-care personnel. The product is presented sterile (SAL = 1 x 10-6) in peel-pack pouches each containing 1 unit. Sterility is achieved using a validated ethylene oxide sterilization process. Gri-fill Peristaltic Set is not intended to be used for direct patient contact.
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K Number
K102590Device Name
FLEBOSET DOUBLE
Manufacturer
LABORATORIOS GRIFOLS, S.A.
Date Cleared
2011-01-13
(126 days)
Product Code
LHI
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
LABORATORIOS GRIFOLS, S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable transfer set through which substances from 2 different vials containing the same solution may be continuously delivered for:
- IV administration when used in conjunction with a gravity or pump infusion set, with a) luer-lock connection to the drip chamber, to channel the solution from the source vials to the infusion set, and
- Pharmacy Compounding when used in conjunction with the Grifill 3.0 pharmacy b) compounding device and associated transfer sets.
Equipped with a spike on each line and a 0.2 um hydrophobic air-filter, it minimizes the formation of aerosols when preparing / dispensing the source substances. Facilitates easy puncture of thick rubber stoppers of small diameter. Provides fast fluid addition and extraction due to the large sufface area of the air-filter.
Set tubing is PVC with DEHP plasticizer. Do not use with lipids, suspensions or solutions that are incompatible with PVC with DEHP plasticizer. Substances that are known to show incompatibility include, but are not limited to, Pacitaxel, Etoposide, Carmustine, Propofol, Nitrogycerin, Isosorbide Dinitrate, Diazepam. For information concerning compatibility of substances, please consult the information provided by the manufacturer.
This device is intended to be used by trained healthcare personnel. It is restricted to sale by or on the order of a physician.
Device Description
Disposable fluid transfer set for connection to a gravity or pump 1.V. administration set with drip chamber with luer lock connector or for use with the Gri-fill 3.0 pharmacy compounder.
Equipped with a spike on each line and a 0.2 um hydrophobic air-filter, it minimizes the formation of aerosols when preparing / dispensing the source substances. Facilitates easy puncture of thick rubber stoppers of small diameter. Provides fast fluid addition and extraction due to the large surface area of the air-filter.
Set tubing is PVC with DEHP plasticizer. Do not use with lipids, suspensions or solutions that are incompatible with PVC with DEHP plasticizer. Substances that are known to show incompatibility include, but are not limited to, Paclitaxel, Docetaxel, Etoposide, Carmustine, Propofol, Nitroglycerin, Isosorbide Dinitrate, Diazepam, For information concerning compatibility of substances, please consult the information provided by the manufacturer.
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K Number
K093182Device Name
SET GRI-FILL 3.0
Manufacturer
LABORATORIOS GRIFOLS, S.A.
Date Cleared
2010-01-27
(111 days)
Product Code
LHI
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
LABORATORIOS GRIFOLS, S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SET GRI-FILL 3.0 6 to 1 is a fluid transfer set to be used in conjunction with SETS GRI-FILL 3.0 1 WAY or 2 WAY through which the same substance from up to 6 rubberstoppered glass vials may be delivered into a final IV container.
SET GRI-FILL 3.0 6 TO 1 is an ancillary device used as a fluid pathway in conjunction with the Gri-fill 3.0 Pharmacy Compounder and associated 1 way or 2 way transfer sets through which the same substance from up to 6 rubber-stoppered glass vials may be delivered into a final IV container. Equipped with a spike on each line and a 0.2 µm hydrophobic air-filter, it minimizes the formation of aerosols when preparing / dispensing the source substances. Facilitates easy puncture of thick rubber stoppers of small diameter. Provides fast fluid addition and extraction due to the large surface area of the air-filter.
This device should not be used with lipids, suspensions or solutions that are incompatible with PVC with DEHP plasticizer. Substances that are known to show incompatibility include, but are not limited to, Paclitaxel, Docetaxel, Etoposide, Carmustine, Propofol, Nitroglycerin, Isosorbide Dinitrate and Diazepam. For information concerning compatibility of substances, please consult the information provided with the substance.
Device Description
Fluid transfer set consisting of PVC tubing linking 6 minispikes to be used in conjunction with SETS GRI-FILL 3.0 1 Way or 2 Way transfer sets 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.
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K Number
K082752Device Name
QUICKPIN
Manufacturer
LABORATORIOS GRIFOLS, S.A.
Date Cleared
2008-09-29
(10 days)
Product Code
LHI
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
LABORATORIOS GRIFOLS, S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
QUICKPIN is a Luer-lock spike used in manual or automated pharmacy compounding for addition and / or extraction of IV substances, including antineoplastics and substances for chemotherapy, from rubber-stoppered containers including multidose vials. It is equipped with a 0.2 micron hydrophobic air-filter that minimizes the formation of aerosols when preparing and dispensing the substances. This device is intended to be used by trained healthcare personnel. It is restricted to sale by or on the order of a physician.
Device Description
QUICKPIN is a Luer-lock spike used in manual or automated pharmacy compounding for addition and/or extraction of IV substances, including antineoplastics and substances for chemotherapy, from rubber-stoppered containers including multi-dose vials. It is equipped with a 0.2 micron hydrophobic air-filter that minimizes the formation of aerosols when preparing and dispensing the substances.
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K Number
K050339Device Name
SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE
Manufacturer
LABORATORIOS GRIFOLS, S.A.
Date Cleared
2005-02-25
(14 days)
Product Code
LHI
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
LABORATORIOS GRIFOLS, S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SETS GRI-FILL 3.0 1 WAY and 2 WAY fluid transfer sets are ancillary devices used in the GRI-FILL 3.0 pharmacy compounder in the hospital pharmacy to provide a fluid pathway through which one or two source substances are delivered into a final IV container or syringe.
SETS GRI-FILL 3.0 MULTIPLE fluid transfer sets are ancillary devices used as fluid pathways in conjunction with the GRI-FILL 3.0 pharmacy compounder and associated 1 WAY or 2 WAY transfer sets through which the same substance from up to 6 source containers may be delivered into a final IV container.
This device should not be used with lipids.
This device is intended to be used by trained health-care personnel. It is restricted to sale by or on the order of a physician.
Device Description
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 1WAY / 2WAY 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 1WAY / 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.
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K Number
K040456Device Name
FLEBOSET MULTIPLE
Manufacturer
LABORATORIOS GRIFOLS, S.A.
Date Cleared
2004-03-09
(15 days)
Product Code
LHI
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
LABORATORIOS GRIFOLS, S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FLEBOSET MULTIPLE is an ancillary device used as fluid pathway through which substances from 6 glass source flasks containing the same solution may be continuously delivered for:
- (a) Pharmacy compounding, when used in conjunction with the GRI-FILL 2.0 pharmacy compounding device and associated transfer sets, and
- (b) I.V. administration, when used in conjunction with a gravity or pump infusion set to channel the solution from the source containers to the infusion set.
The device should not be used with lipids.
This device is intended to be used by trained health-care personnel. It is restricted to sale by or on order of a physician.
Device Description
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 I.V. fluid transfer to minimize tubing manipulation when working with small volume source containers. The device is made up of 6 spikes connected in series with flexible tubing segments, each segment with an individual clamp. The set terminal, for connection to pharmacy compounding device sets or the administration sets (gravity or pump) consists of a spikeable twist-off valve connector.
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K Number
K033916Device Name
GRI-BAG, GRI-BAG AP
Manufacturer
LABORATORIOS GRIFOLS, S.A.
Date Cleared
2003-12-30
(12 days)
Product Code
KPE, FPB, NEP
Regulation Number
880.5025Why did this record match?
Applicant Name (Manufacturer) :
LABORATORIOS GRIFOLS, S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
All models of GRI-BAG are flexible I.V. bags, with incorporated 0.2 urn 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.
Device Description
GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 um 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 GRI-BAG AP models have a conus vial output connector.
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K Number
K033682Device Name
SET GRI-FILL 2.0-1 WAY; 2.0-2 WAYS; LUER CONNECTION TUBE
Manufacturer
LABORATORIOS GRIFOLS, S.A.
Date Cleared
2003-12-17
(23 days)
Product Code
LHI, NEP
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
LABORATORIOS GRIFOLS, S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
All models of SETS GRI-FILL 2.0 fluid transfer sets are ancillary devices used in conjunction with the GRI-FILL 2.0 pharmacy compounding device in hospites in hospites for a macy to provide a fluid pathway through which one or more source solutions are delivered into a single Gri-bag or Gri-flex container or into a standard syringe or pump. The device should not be used with lipids. It is restricted to sale by or on order of a physician.
Device Description
SETS GRI-FILL 2.0 are fluid transfer sets for use with the GRI-FILL 2.0 pharmacy compounding device in order tc compound or mix different multi-ingredient solutions and to channel them into a final suitable container. The set is a disposable component of the compounding device made up of a syringe, a distributor and tubing to channel the fluid. Sets are available for 1 or 2 source solutions. Also a Luer female - female adapter is available as an accessory to the 1 or 2 way transfer sets. The model Luer Connection Tube can be joined to the 1 way or 2 ways sets as prolongation for connection to source solution containers with luer terminals.
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K Number
K031419Device Name
GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML
Manufacturer
LABORATORIOS GRIFOLS, S.A.
Date Cleared
2003-11-24
(203 days)
Product Code
KPE, FPB, NEP
Regulation Number
880.5025Why did this record match?
Applicant Name (Manufacturer) :
LABORATORIOS GRIFOLS, S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
All models of GRI-FLEX are flexible I.V. bags, with incorporated 0.2 um 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.
Device Description
GRI-FLEX is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µm 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.
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