BEUDAMED
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    18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Assembly, Dash Final PDM U100, mmol/L PT-000030: Assembly, DASH PDM, Canada Remote Controller (Personal Diabetes Manager or PDM) associated with Insulin Pump (Pod) *The part numbers above may be incorporated into higher level assemblies such as DASH Starter Kits.

    FDA Enforcement
    Class I ·Terminated·Insulet Corporation·November 23, 2022

    Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system designed to automate sample handling and processing in the clinical laboratory. The system allows consolidations of multiple clinical chemistry and immunoassay analytical instruments into a unified workstation.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories·June 10, 2020

    PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim sutures and catheters up to 6Fr. Models PB-M-10, PB-M-11P, PB-M-15

    FDA Enforcement
    Class II ·Terminated·Zien Medical Technologies, Inc·September 30, 2015

    Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-000428: Adaptor, Charging, Noetic Nuu N5004L, Horizon PDM, US PT-000429: Cable, Charging, Omnipod 5, Horizon PDM

    FDA Enforcement
    Class II ·Ongoing·Insulet Corporation·December 14, 2022

    GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·November 29, 2023

    Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-000011 M/D: INT1-D001-MM UDI 10385082000009 The Omnipod DASH Personal Diabetes Manager (PDM) is a mobile, handheld Android device that is intended to communicate with the Omnipod DASH Pod (pump).

    FDA Enforcement
    Class II ·Terminated·Insulet Corporation·April 1, 2020

    GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·November 29, 2023

    UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, & 330430S

    FDA Enforcement
    Class II ·Terminated·NewDeal SA·July 25, 2018

    CARESCAPE PDM-Masimo SpO2. Physiological data monitor.

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare, LLC·August 4, 2021

    Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a major component of the Merge Hemo system.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·May 10, 2017

    GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00024345009, 00024360009

    FDA Enforcement
    Class II ·Ongoing·Instrumentation Laboratory·November 29, 2023

    Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170

    FDA Enforcement
    Class II ·Ongoing·Alere San Diego, Inc.·May 8, 2024

    Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037

    FDA Enforcement
    Class II ·Terminated·BioPro, Inc.·March 9, 2022

    CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software The PDM is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes EGG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes.

    FDA Enforcement
    Class II ·Terminated·GE Medical Systems Information Technologies, Inc.·December 13, 2017

    Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1

    FDA Enforcement
    Class II ·Terminated·Insulet Corporation·November 13, 2019

    The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·July 19, 2017

    The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·February 22, 2017

    The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of intermittent bolus doses of medication based on patient demand.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corp.·May 6, 2015

    POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.

    FDA Enforcement
    Class II ·Terminated·POM Medical LLC·November 6, 2019

    ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.

    FDA Enforcement
    Class II ·Terminated·Pfm Medical Inc·December 17, 2014