ClearanceBrief
Panels › General Hospital › Product code KPE · Class 2

Container, I.V.

Regulation 880.5025

3510(k)s in 12 months (117 all time)
0recalls in 12 months (62 all time)
57recalls that name a 510(k)
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Top companies in KPE

DateFirm and productCodeLinked 510(k)
Nov 8, 2024The Metrix Company
Imed Products Imed EVA BAG, 1000 mL, 2-PORTS, REF IM68055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Open, Classified
KPEK030888
Nov 8, 2024The Metrix Company
Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Open, Classified
KPEK030888
Nov 8, 2024The Metrix Company
Imed Products Imed EVA BAG, 250 mL, 2-PORTS, REF IM68045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Open, Classified
KPEK030888
Nov 8, 2024The Metrix Company
Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Open, Classified
KPEK030888
Nov 8, 2024The Metrix Company
SECURE 1000 mL EMPTY EVA CONTAINER With 2 Ports, REF 66055; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Open, Classified
KPEK030888
Nov 8, 2024The Metrix Company
SECURE 500 mL EMPTY EVA CONTAINER With 2 Ports, REF 66050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Open, Classified
KPEK030888
Nov 8, 2024The Metrix Company
SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Open, Classified
KPEK030888
Nov 8, 2024The Metrix Company
SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed) , REF 66043; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Open, Classified
KPEK030888
Nov 8, 2024The Metrix Company
SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Open, Classified
KPEK030888
Nov 8, 2024The Metrix Company
SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports (Bulk Packed), REF 66041; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Open, Classified
KPEK030888
Nov 8, 2024The Metrix Company
SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Open, Classified
KPEK030888
Nov 8, 2024The Metrix Company
CORMIX 500 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Open, Classified
KPEK030888
Nov 8, 2024The Metrix Company
CORMIX 250 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Open, Classified
KPEK030888
Nov 8, 2024The Metrix Company
CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Open, Classified
KPEK030888
Nov 8, 2024The Metrix Company
VYGON 250 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9602; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Open, Classified
KPEK030888
Nov 8, 2024The Metrix Company
VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
Open, Classified
KPEK030888
Aug 16, 2024ROi CPS LLC
Regard Kit containing the Microtek decanter
Open, Classified
KPENone listed
Aug 16, 2024Microtek Medical Inc.
Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Open, Classified
KPEK811268
Aug 16, 2024Microtek Medical Inc.
Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Open, Classified
KPEK811269
Aug 16, 2024Microtek Medical Inc.
Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Open, Classified
KPEK811234
Aug 16, 2024Microtek Medical Inc.
Bag Decanter II, REF 2002S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Open, Classified
KPEK811233
Aug 16, 2024Microtek Medical Inc.
C-Flow Bag Decanter, REF 2000S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
Open, Classified
KPEK811233
Jan 11, 2023Stradis Healthcare
HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
Open, Classified
KPEK190328
Jan 11, 2023Stradis Healthcare
HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
Open, Classified
KPEK190328
Aug 26, 2022Mckesson Medical-Surgical Inc. Corporate Office
B. Braun EVA Gravity Mixing Container 1000 mL Model Number: 2112363
Open, Classified
KPEK041415
Nov 2, 2018Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
Terminated
KPEK900585
Nov 2, 2018Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
Terminated
KPEK900585
Nov 2, 2018Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
Terminated
KPEK900585
Nov 2, 2018Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
Terminated
KPEK900585
Nov 2, 2018Baxter Healthcare Corporation
EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
Terminated
KPEK900585
Sep 21, 2018The Metrix Company
ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250 ml/ 1250 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be fi
Open, Classified
KPEK960581
Sep 21, 2018The Metrix Company
ExactaMix, Model: H938901, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 500 ml/ 2500 ml, Baxter - Product Usage: For use in an intravenous admixture program. The empty container will be fi
Open, Classified
KPEK960581
Sep 21, 2018The Metrix Company
SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with paren
Open, Classified
KPEK960581
Sep 21, 2018The Metrix Company
SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with paren
Open, Classified
KPEK960581
Sep 21, 2018The Metrix Company
SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with paren
Open, Classified
KPEK960581
Sep 21, 2018The Metrix Company
SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 4000mL, (legless) REF 66640 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral
Open, Classified
KPEK960581
Sep 21, 2018The Metrix Company
SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral
Open, Classified
KPEK960581
Sep 21, 2018The Metrix Company
SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral
Open, Classified
KPEK960581
Jan 11, 2018Baxter Healthcare Corporation
Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
Terminated
KPEK964853
Sep 29, 2017The Metrix Company
SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R,
Terminated
KPEK843523
Oct 31, 2014Baxter Healthcare Corp
Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories The lntraVia Empty Plastic Container is intended for use in th
Terminated
KPEK964853
Oct 31, 2014Baxter Healthcare Corp
Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plastic Container is intended for use in the preparation an
Terminated
KPEK964853
Sep 17, 2012Hospira Inc.
Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections.
Terminated
KPENone listed
Aug 2, 2010Baxa Corporation
Exacta - Mix Valve Set, Six Inlet, Tubing Kit w/Calibration Bag, Fluid Path is sterile and non-pyrogenic in unopened, undamaged package, 250 mL, Order No. REF: 706D, Baxa Corporation.
Terminated
KPEK900585
Aug 2, 2010Baxa Corporation
Exacta-Mix Valve Set, Six Inlet, Non-Vented, Assembled, Tubing Kit w/Calibration Bag, Sterile R, non-pyrogenic fluid path, 250 mL, Order No. REF 706, Baxa Corporation.
Terminated
KPEK900585
Aug 2, 2010Baxa Corporation
Exacta-Mix 2400 Valve Assembly w/Calibration Bag, Sterile R, 250 mL, Order No. REF: 724, Baxa Corporation.
Terminated
KPEK900585
Aug 2, 2010Baxa Corporation
Exacta-Mix Calibration Bag, Sterile R, non-pyrogenic fluid path, 250 mL Reorder No. H938 371 3, Manufactured for Baxa Corporation.
Terminated
KPEK900585
Aug 2, 2010Baxa Corporation
Halobag EVA Dual-Chamber Bag, Sterile R, 3000 mL Total Volume W/500 mL upper chamber, Order No. REF: 341, Baxa Corporation.
Terminated
KPEK900585
Aug 2, 2010Baxa Corporation
Exacta-Mix EVA Container, Sterile R, 5000 mL, Order No. REF: 143, Baxa Corporation.
Terminated
KPEK900585
Aug 2, 2010Baxa Corporation
Exacta-Mix EVA Container, Sterile R, 4000 mL, Order No. REF: 142, Baxa Corporation.
Terminated
KPEK900585

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