BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Nellcor Pulse Oximeter Probe

    DI: 00816317020552 · Model: RM-MAX-I · RENU MEDICAL, INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Nellcor Pulse Oximeter Probe
    Primary DI
    00816317020552
    Version / Model
    RM-MAX-I
    Company Name
    RENU MEDICAL, INC
    Labeler DUNS
    100439103
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-23
    Public Version
    6
    Public Version Date
    2023-09-08
    Public Version Status
    Update
    Public Device Record Key
    6010c43f-5a21-438b-8d26-e130e311d7dc

    Device Description

    Nellcor OxiMax MAX-I INFANT

    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
    Yes
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NLF Oximeter, Reprocessed

    GMDN Terms

    Code Name
    36087 Pulse oximeter probe, reprocessed

    Identifiers

    Type ID
    Package 10816317020559
    Primary 00816317020552

    Premarket Submissions

    Submission Number Supplement Number
    K111773 000