ASEPT PERITONEAL DRAINAGE SYSTEM
ASEPT - 622284
Device Description
A sterile flexible tube designed for percutaneous insertion into the peritoneal space typically to drain ascites and abdominal abscesses. It may include disposable devices dedicated to catheter introduction, however it does not include any fluid collection bags/containers. This is a single-use device.
Environmental Conditions
- KEEP DRY
- Keep away from sunlight
- Store at room temp
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: PNG
Device Name: Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
Device Class: 2
Physical State: Plastic tubing with a tissue ingrowth cuff and valve or connector.
Definition: For drainage of refractory ascites with long-term occurrence from the peritoneal cavity.
Submission Type ID: 1
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Typically attached to positive pressure or gravity feed to assist in drainage of fluid from the peritoneal cavity.
Life Sustain Support Flag: Y
Unclassified Reason: N/A
Implant Flag: Y
Target Area: Peritoneal Cavity.
Regulation Number: 876.5630
Third Party Flag: N
Medical Specialty: GU
Device IdentifiersDevice Id: 04046964317330
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