Portex - 100/199/060
Device Description
A flexible device designed to promote conception, either by serving as a container to introduce semen into the cervix, or by acting as a cervical cup that allows sperm to be held in place for easier access to the cervical os. It is a plastic device that is typically larger, but shallower, than a contraceptive cap. The device is used to aid conception in couples who have experienced difficulties due to low sperm counts, reduced sperm motility or a hostile vaginal environment; and also for self or assisted insemination. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: BTR
Device Name: Tube, Tracheal (W/Wo Connector)
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: AN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: Y
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 868.5730
Third Party Flag: N
Medical Specialty: AN
Device IdentifiersDevice Id: 35019315022306
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15019315022302
Package Quantity: 20
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX
Device Id: 15019315022302
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: 55019315022300
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 35019315022306
Package Quantity: 6
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
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