Product Overview

Sterile Specimen Container - 070006

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: 37503025060164

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 17503025060160

    Package Quantity: 100

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

    Package Status: Not in Commercial Distribution

    Package Type: Case

    Device Id: 17503025060160

    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

    Educational Resources