BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Pro-Flow

    DI: 00606959040205 · Model: AIR FLOW,CANNULA SAMPLE PACK · Respironics, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Pro-Flow
    Primary DI
    00606959040205
    Version / Model
    AIR FLOW,CANNULA SAMPLE PACK
    Catalog Number
    P1258
    Company Name
    Respironics, Inc.
    Labeler DUNS
    080728314
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-18
    Public Version
    5
    Public Version Date
    2022-03-22
    Public Version Status
    Update
    Public Device Record Key
    917e6a4d-4230-48d7-9888-1b4854aa4cd2

    Device Description

    AIR FLOW,CANNULA SAMPLE PACK Cannula sample pack includes two of each of the following part numbers P1294 and P1257. P1294 was issued a UDI number 00606959032248 and P1257 was issued a UDI 00606959032200.

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CCK ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

    GMDN Terms

    Code Name
    35201 Nasal oxygen cannula, basic

    Identifiers

    Type ID
    Primary 00606959040205

    Customer Contacts

    Phone
    +1(724)744-2500
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K053063 000

    Storage Conditions

    Type
    Storage Environment Humidity
    Temperature Range
    15 – 95 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 60 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    -4 – 140 Degrees Fahrenheit