BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ANNE Pediatric

    DI: 00860004541721 · Model: SA-011 · Sibel Health Inc.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ANNE Pediatric
    Primary DI
    00860004541721
    Version / Model
    SA-011
    Company Name
    Sibel Health Inc.
    Labeler DUNS
    093772547
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-22
    Public Version
    2
    Public Version Date
    2023-11-01
    Public Version Status
    Update
    Public Device Record Key
    33eba62c-a1ec-4da7-9cbb-0ebde32fc871

    Device Description

    ANNE Pediatric is a wireless vital signs monitoring platform for use on neonatal patients of any gestational age up to infants 2 years of age.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
    MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
    FLL Thermometer, Electronic, Clinical

    GMDN Terms

    Code Name
    12391 Wearable multiple physiological parameter recorder, reusable

    Identifiers

    Type ID
    Primary 00860004541721