Portex - 100/199/055
Device Description
A tubular device designed for percutaneous insertion into the bladder or renal pelvis through the suprapubic region. It typically consists of a metallic tube or a semi-rigid or rigid plastic tube that includes a trocar in its lumen to assist in the insertion and provide rigidity. The trocar is withdrawn after insertion leaving a hollow channel that is used for the drainage of urine, and/or for the insertion of a catheter or other appropriate device. 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: 55019315022294
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 35019315022290
Package Quantity: 6
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
Device Id: 35019315022290
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15019315022296
Package Quantity: 20
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX
Device Id: 15019315022296
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