BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Datex-Ohmeda, Inc.

    Reg #: 3036470679 · FEI: 3036470679 · Expires 2026
    View on FDA
    Products
    12
    Proprietary Names
    83
    Establishment Types
    1
    Classifications
    12

    Registration Details

    Registration Name
    Datex-Ohmeda, Inc.
    Registration Number
    3036470679
    FEI Number
    3036470679
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3114 N Grandview Blvd
    City
    Waukesha
    State
    WI
    ZIP
    53188
    Country
    US

    Regulatory Submissions

    510(k) Number
    K101788

    Owner / Operator

    Firm Name
    GE HealthCare Technologies Inc.
    Operator Number
    9912004
    Address
    3000 N. Grandview Blvd
    City
    Waukesha
    State
    WI
    Postal Code
    53188
    Country
    US

    Products

    Device Name Product Code
    Incubator, Neonatal FMZ
    Warmer, Infant Radiant FMT
    Ventilator, Emergency, Powered (Resuscitator) BTL
    Unit, Neonatal Phototherapy LBI
    Uterine Electromyographic Monitor OSP
    Cable, Electrode IKD
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Stand, Infusion FOX
    Mattress, Flotation Therapy, Non-Powered IKY
    Electrode, Electrocardiograph DRX
    Scale, Patient FRW
    System, Monitoring, Perinatal HGM

    Proprietary Names

    Giraffe OmniBed + Shuttle Giraffe Omnibed Giraffe Shuttle Panda Warmer Giraffe Warmer Giraffe Incubator + Shuttle Giraffe Incubator Panda iRes Warmer Giraffe Stand-alone Infant Resuscitation System (T-piece) StAR Giraffe Stand-alone Infant Resuscitation System (T-piece, and Bag and Mask) Giraffe Stand-alone Infant Resuscitation System Giraffe Incubator Carestation CS1 Giraffe Incubator Carestation Giraffe Panda Disposable Infant Skin Temperature Probe Disposable Infant Skin Temperature Probe Lullaby Warmer Giraffe OmniBed Carestation Giraffe OmniBed Carestation CS1 Giraffe Omnibed Carestation CS1 Giraffe OmniBed Blue Spot PT Giraffe Blue Spot PT Lite Blue Spot PT Lite Novii Novii Wireless Patch System Novii Interface Novii Pod ECG Trunk Cables and Leadwires Trunk Cables (Cardiac Output Cables, Invasive Blood Pressure Cables, Temperature Cables) ECG Adapter Cable NOVII INTERFACE CABLE - GE FECG MECG Cable FECG Cable CLAB ECG Trunk Cable 12-lead AHA 10ft CLAB ECG Trunk Cable 12-lead IEC 10ft NOVII INTERFACE CABLE - GE MECG Novii Cables (NOVII INTERFACE CABLE - GE FECG; NOVII INTERFACE CABLE - GE MECG; NOVII INTERFACE CABLE - GE UA) 4 Leadwire Expansion Cable, grabber, IEC, 74 cm/29 in. NOVII INTERFACE CABLE - GE UA 4 Leadwire Expansion Cable, snap, IEC, 74 cm/29 in. 4 Leadwire Expansion Cable, grabber, IEC, 130 cm/51 in. Cable assembly ECG 3 lead neo IEC long, 3.6 m Cable assembly ECG 3 lead neo AHA short, 1.8 m Cable assembly ECG 3 lead neo AHA long, 3.6 m 4 Leadwire Expansion Cable, snap, IEC, 130 cm/51 in. Cable assembly ECG 3 lead neo IEC short, 1.8 m 4 Leadwire Expansion Cable, snap, AHA, 130 cm/51 in. 4 Leadwire Expansion Cable, grabber, AHA, 74 cm/29 in. 4 Leadwire Expansion Cable, snap, AHA, 74 cm/29 in. 4 Leadwire Expansion Cable, grabber, AHA, 130 cm/51 in. BiliSoft 2 Phototherapy System BiliSoft LED Phototherapy System BiliSoft BiliSoft Phototherapy System Giraffe Warmer (Uninterruptible Power Supply) Panda Warmer (Uninterruptible Power Supply) Giraffe Stand-alone Infant Resuscitation System (Bag and Mask) Giraffe and Panda Bag and Mask Resuscitation System Panda iRes IV Pole ROTATING IV POLE Rotating IV1 IV POLE ASSY 12 IN 12 Inch IV1 IV POLE ASSY 24 IN 24 Inch IV1 LULLABY IV POLE IV1 Pressure Diffusing Mattress GIRAFFE PRESSURE DIFFUSING MATTRESS Novii Patch Patient Scale Giraffe Scale Giraffe In-Bed Scale GS1 Panda EU In-Bed Scale PS EU1 Giraffe EU In-Bed Scale GS EU1 Panda In-Bed Scale PS1 Panda Scale Panda Freestanding Warmer Panda Wall Mount Warmer Panda Ires Warmer Lullaby LED PT Lullaby LED Phototherapy System Novii+ Wireless Patch System Novii+ Interface Novii+ Pod

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility