BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Jaeger Medical America Inc.

    Reg #: 3033959233 · FEI: 3033959233 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    42
    Establishment Types
    2
    Classifications
    20

    Registration Details

    Registration Name
    Jaeger Medical America Inc.
    Registration Number
    3033959233
    FEI Number
    3033959233
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    14050 Rebecca St Bldg 4
    City
    Moreno Valley
    State
    CA
    ZIP
    92553
    Country
    US

    Regulatory Submissions

    510(k) Number
    K942211

    Owner / Operator

    Firm Name
    Jaeger Medical GmbH
    Operator Number
    10092652
    Address
    Leibnizstrasse 7
    City
    Hoechberg
    State
    Bavaria
    Postal Code
    97204
    Country
    DE

    Products

    Device Name Product Code
    Mouthpiece, Breathing BYP
    Regulator, Pressure, Gas Cylinder CAN
    Clip, Nose BXJ
    Calculator, Predicted Values, Pulmonary Function BTY
    Computer, Diagnostic, Programmable DQK
    Calculator, Pulmonary Function Data BZC
    Calibrator, Volume, Gas BXW
    Oximeter DQA
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Monitor, St Segment MLC
    Electrocardiograph DPS
    Analyzer, Gas, Oxygen, Gaseous-Phase CCL
    Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase CCJ
    Plethysmograph, Volume JEH
    Spirometer, Diagnostic BZG
    Filter, Bacterial, Breathing-Circuit CAH
    Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) CBR
    Transducer, Gas Flow BXP
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Analyzer, Gas, Helium, Gaseous-Phase BSE

    Proprietary Names

    Disposable Mouthpiece, Flex V-892894 Disposable Mouthpiece, plastic 892103 Disposable Mouthpiece, plastic V-892896 Disposable Mouthpiece, Flex V-892893 Disposable Mouthpiece, Flex V-892897 Gas Cylinder 706960 Pressure Regulator Nose clip reusable V-892895 Nose clip single patient use V-892900 Nose clip pad single patient use 892121 Vmax 229 Series Sentry WEB Smartinterp MasterScreen Pneumo APS Pro MasterScreen CPX & Oxycon CPX Vyntus / SentrySuite Product Line Vyntus ECG Vyntus CPX, Vyntus / SentrySuite Product Line Calibration Syringe V-720254-13 JQM Syringe V-720000-13 Vyntus WALK Vyntus SPIRO Vyntus CPX / Vyntus ECG O2 Test Static and Dynamic Compliance for Vmax CO Test MasterScreen PFT Body MasterScreen IOS (JLAB 5.x) MicroGard II Filter Kit MicroGard II Filter MS CPX partially mobile N2O Test SentrySuite Product Line 2.7 SentrySuite Product Line 2.3 V-707377 USS Module CO2 Test MasterScreen Diffusion MasterScreen Body Vyntus BODY Vyntus ONE SentrySuite Product Line 2.5 HE TEST

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198