Portex - 100/386/010
Device Description
A microporous membrane used to minimize particulate (foreign material) contamination of a local anaesthetic during subcutaneous administration to a patient (e.g., through a spinal or epidural catheter); it may in addition be intended for use during medication administration or preparation. 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: False
Sterilization Methods: No Data Available
Product Codes
Code: BSN
Device Name: Filter, Conduction, Anesthetic
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: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 868.5130
Third Party Flag: Y
Medical Specialty: AN
Device IdentifiersDevice Id: 15019315023385
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: 35019315023389
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15019315023385
Package Quantity: 10
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BAG
Device Id: 55019315023383
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 35019315023389
Package Quantity: 70
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CARTON
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