46 results
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8ms
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Sources: EU EUDAMED, US FDA
99 IN (251cm) APPX 12.6ml, 20 Drop, 2 Clave, 2 NanoClave 4-Way Stopcocks, Drop-In Ext, Clave; 1 unit per pouch, 25 pouches per case. UDI: (01)10887709066318(17)241201(30)25(10)4515251; (01)10887709066318(17)241201(30)25(10)4537242. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·October 28, 2020
6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave, NanoClave T-Connector, Purple Clamp, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062525(17)250101(30)50(10)4558455; (01)10887709062525(17)241201(30)50(10)4537168; (01)10887709062525(17)241201(30)50(10)4493389. The high pressure extension set is a device used as conduit tubing to deliver fluids from an ~f electronic or manual injector and may also be used as connector tubing to provide a sterile fluid pathway between two devices.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·October 28, 2020
7 IN (18cm) APPX 1.2ml Ext Set w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709067582(17)241201(30)50(10)4548270; (01)10887709067582(17)250101(30)50(10)4558614; (01)10887709067582(17)250201(30)50(10)4733732; (01)10887709067582(17)241201(30)50(10)4493665. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·October 28, 2020
2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053172(17)241201(30)50(10)4493459;(01)10887709053172(17)241201(30)50(10)4536673. The ICU Medical Clave Stopcock is a device used to administer or withdraw fluids that flow from a container to a patient's vascular system through a needle or catheter inserted into a vein or artery. This device is a four-way stopcock with an integral CLAVE side-port for closed, needleless access to the patient tubing or other fluid container.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·October 28, 2020
NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)10840619060906(17)250101(30)100(10)4559476; (01)10840619060906(17)250201(30)100(10)4711354; (01)10840619060906(17)241101(30)100(10)4476111; (01)10840619060906(17)241201(30)100(10)4493213; (01)10840619060906(17)241201(30)100(10)4510900; (01)10840619060906(17)250301(30)100(10)4749152. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to a patients vascular system through the administrations set needle or catheter, which is inserted into the vein.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·October 28, 2020
7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051048(17)250101(30)50(10)4572718; (01)10887709051048(17)250101(30)50(10)4603246; (01)10887709051048(17)250201(30)50(10)4718507; (01)10887709051048(17)241201(30)50(10)4537122; (01)10887709051048(17)241201(30)50(10)4549054; (01)10887709051048(17)250201(30)50(10)4734370. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·October 28, 2020
APPX 0.75 ml, 6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709070551(17)241201(30)50(10)4542066; (01)10887709070551(17)241201(30)50(10)4549203; (01)10887709070551(17)250101(30)50(10)4558619; (01)10887709070551(17)250101(30)50(10)4589971; (01)10887709070551(17)250101(30)50(10)4605186; (01)10887709070551(17)250201(30)50(10)4733735. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·October 28, 2020
142 IN (361cm) APPX 18.8 ml, 15 DROP SET 4 MicroClave CLEAR, REMV 3-PORT NanoClave w/ BCV. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709089393(17)250101(30)25(10)4573948;(01)10887709089393(17)250101(30)25(10)4603380; (01)10887709089393(17)250101(30)25(10)4711169; (01)10887709089393(17)241201(30)25(10)4493653; (01)10887709089393(17)241201(30)25(10)4536737; (01)10887709089393(17)250201(30)25(10)4733710. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·October 28, 2020
NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)10887709058757(17)250101(30)100(10)4573278; (01)10887709058757(17)250101(30)100(10)4590919; (01)10887709058757(17)250201(30)100(10)4712217; (01)10887709058757(17)241201(30)100(10)4537440; (01)10887709058757(17)241201(30)100(10)4549906; (01)10887709058757(17)250101(30)100(10)4559515; (01)10887709058757(17)250201(30)100(10)4719743; (01)10887709058757(17)250201(30)100(10)4726897; (01)10887709058757(17)250201(30)100(10)4735597; (01)10887709058757(17)241101(30)100(10)4461205. CLAVE Neutron is a normally closed, bidirectional connector intended for use as an accessory to an Intravascular catheter placed in the vein or artery. The device may be used for the administration of blood and fluids to patients, including pediatrics and immunocompromised patients. .
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·October 28, 2020
8" (20 cm) Appx 0.33 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave Clamp, Rotating Luer.1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062946(17)250101(30)50(10)4603254; (01)10887709062946(17)250201(30)50(10)4630684; (01)10887709062946(17)250201(30)50(10)4718516; (01)10887709062946(17)241201(30)50(10)4514832; (01)10887709062946(17)241201(30)50(10)4537159; (01)10887709062946(17)250101(30)50(10)4558447; (01)10887709062946(17)250201(30)50(10)4724820; (01)10887709062946(17)250201(30)50(10)4733554. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·October 28, 2020
5.5" (14 cm) Appx 0.28 ml, Smallbore Ext Set w/NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709077758(17)250101(30)50(10)4603285;(01)10887709077758(17)250101(30)50(10)4603285; (01)10887709077758(17)250101(30)50(10)4630700; (01)10887709077758(17)250301(30)50(10)4749870; (01)10887709077758(17)241201(30)50(10)4514843; (01)10887709077758(17)241201(30)50(10)4549093; (01)10887709077758(17)250101(30)50(10)4558478; (01)10887709077758(17)250201(30)50(10)4724850; (01)10887709077758(17)250201(30)50(10)4734400. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·October 28, 2020
6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case; UDI:(01)10887709051024(17)250101(30)50(10)4603240;(01)10887709051024(17)250201(30)50(10)4714349; (01)10887709051024(17)250201(30)50(10)4733540; (01)10887709051024(17)250201(30)50(10)4724812; (01)10887709051024(17)241201(30)50(10)4515226; (01)10887709051024(17)241201(30)50(10)4537113; (01)10887709051024(17)250101(30)50(10)4557474; (01)10887709051024(17)250201(30)50(10)4718500; (01)10887709052793(17)250101(30)50(10)4557476; (01)10887709052793(17)250101(30)50(10)4590957; The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·October 28, 2020
NanoClave Connector; 1 unit per pouch, 100 multivac pouches per case;UDI (01)10887709051017(17)241201(30)100(10)4549051; (01)10887709051017(17)241101(30)100(10)4447754 CLAVE Neutron is a normally closed, bidirectional connector intended for use as an accessory to an Intravascular catheter placed in the vein or artery.
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·October 28, 2020
APPX 0.75ml, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple, Yellow Rings)BCV. 1 unit per pouch, 50 pouches per case. UDI: (01)10840619083929(17)241201(30)50(10)4496182. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to a patients vascular system through the administrations set needle or catheter, which is inserted into the vein
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·October 28, 2020
165cm (65 IN)APPX 2.2ml, PUR EXT SET, 3-PORT NanoClave MANIFOLD, BCV, NanoClave. 1 unit per pouch, 50 pouches per case. UDI:(01)10840619062761(17)241201(30)50(10)4553703. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to a patients vascular system through the administrations set needle or catheter, which is inserted into the vein
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·October 28, 2020
11 IN (28cm) APPX 1.5ml EXT SET NanoClave, 6-Port NanoClave Manifold . 1 unit per pouch, 50 pouches per case. UDI:¿(01)10887709098937(17)241201(30)50(10)4493669;(01)10887709098937(17)250101(30)50(10)4558624. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·October 28, 2020
123 IN (312cm) APPX 16.1 ml, 10 DROP SET w/3 MicroClave, 3-Port NanoClave; UDI:(01)10887709085432(17)241201(30)25(10)4536733;(01)10887709085432(17)250101(30)25(10)4573641. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·October 28, 2020
78 IN (198cm) APPX 10.0 ml, 20 Drop Set 3-Port NanoClave Manifold, BCV, MicroClave. 1 unit per pouch, 24 pouches per case.UDI:(01)10887709090634(17)241201(30)25(10)4537328. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·October 28, 2020
58cm (23 IN) APPX 2.1 ml EXT SET Smallbore PUR Yellow w/6-Port Clave, Clave, 2 Clave Stopcock. 1 unit per pouch, 50 pouches per case. UDI: (01)10887709099859(17)241201(30)50(10)4536666. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to a patients vascular system through the administrations set needle or catheter, which is inserted into the vein
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·October 28, 2020
10" (25 cm) Appx 2.8 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri-Connector, NanoClave¿ T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer;1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709052816(17)241201(30)50(10)4537141 The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
FDA Enforcement
Class II
·Terminated·ICU Medical, Inc.·October 28, 2020