Product Overview

60ml/48mmSPCw/LBL, GRN CAP, ST
Sterile Specimen Container - 030008


Device Description

An empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: True

Sterilization Prior To Use: True

Sterilization Methods:

  • Radiation Sterilization
    • Radiation Sterilization


    Product Codes

    Code: FMH

    Device Name: Container, Specimen, Sterile

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: HO

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 864.3250

    Third Party Flag: N

    Medical Specialty: PA


    Device Identifiers

    Device Id: 37503025060126

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 57503025060120

    Package Quantity: 5

    Package Discontinue Date: 7/28/2022 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: Case


    Device Id: 17503025060122

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


    Device Id: 57503025060120

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 17503025060122

    Package Quantity: 100

    Package Discontinue Date: 7/28/2022 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: PACKAGE


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