BEUDAMED
    23 results · 7ms · Sources: EU EUDAMED, US FDA

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    BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer Becton, Dickinson and Company USA BD Medical-Diabetes Care Becton Dickinson France SAS

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·May 10, 2017

    The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·September 7, 2016

    Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, with Eclipse, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3173-98. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

    FDA Enforcement
    Class II ·Terminated·Westmed Inc·October 31, 2012

    Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, with Eclipse, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3165-98. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

    FDA Enforcement
    Class II ·Terminated·Westmed Inc·October 31, 2012

    Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 23g x 1" A Needle w/Eclipse, 25U Balanced Heparin, No CE, part number: 3373-98. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

    FDA Enforcement
    Class II ·Terminated·Westmed Inc·October 31, 2012

    Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 22g x 1" A Needle, 25U Balanced Heparin, part number: 3342-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

    FDA Enforcement
    Class II ·Terminated·Westmed Inc·October 31, 2012

    Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, w/Crickett 25g x 5/8" A Needle, 25U Balanced Heparin, part number: 3165-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

    FDA Enforcement
    Class II ·Terminated·Westmed Inc·October 31, 2012

    Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 22 g x 1" A/B Needle, 25U Balanced Heparin, part number: 3372. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

    FDA Enforcement
    Class II ·Terminated·Westmed Inc·October 31, 2012

    Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3173-14. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

    FDA Enforcement
    Class II ·Terminated·Westmed Inc·October 31, 2012

    Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime CCS Comp Analyzer with Scanner PN 52857 Stat Profile Prime CCS Comp Analyzer Blood Gas/Electrolyte/Metabolite/CO-Oximetry Analyzer

    FDA Enforcement
    Class II ·Terminated·Nova Biomedical Corporation·July 19, 2017

    Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, Luer Slip Barrel, 25U Balanced Heparin, No B Needle or Q-Cork, part number: 3363-95S. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

    FDA Enforcement
    Class II ·Terminated·Westmed Inc·October 31, 2012

    Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 22g x 1" A Needle, 25U Balanced Heparin, part number: 3372-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

    FDA Enforcement
    Class II ·Terminated·Westmed Inc·October 31, 2012

    Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 22g x 1", 25U Balanced Heparin, part number: 3362-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

    FDA Enforcement
    Class II ·Terminated·Westmed Inc·October 31, 2012

    AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER, REF 9025RHTR, 1ML SYRINE 25G 5/8", LUER SLIP PROTECTIVE SHEATH, 3.2 IU, STERILE R, Rx ONLY, CAREFUSION Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured containing the incorrect sub-assembly which includes a larger needle (23 Gage, 1" needle), larger syringe (3mL), and larger amount of heparin (113IU), than what is intended for the kit.

    FDA Enforcement
    Class II ·Terminated·Vyaire Medical·September 6, 2017

    Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, part number: 3373-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

    FDA Enforcement
    Class II ·Terminated·Westmed Inc·October 31, 2012

    Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 23g x 1" A/B Needle, 25U Balanced Heparin, part numbers: 3373, 3393. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

    FDA Enforcement
    Class II ·Terminated·Westmed Inc·October 31, 2012

    Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, part number: 3383-95, 3344-95, 3353-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

    FDA Enforcement
    Class II ·Terminated·Westmed Inc·October 31, 2012

    Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, No B Needle or Q-Cork, part number: 3363-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

    FDA Enforcement
    Class II ·Terminated·Westmed Inc·October 31, 2012

    ADVIA Centaur¿ HBc IgM

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·May 16, 2018

    ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBc Total) in human serum or plasma (potassium EDT A, or lithium or sodium heparinized) using the ADVIA Centaur CP system.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·October 29, 2014