PeritX Drainage Bag, 2000 mL
PeritX - 50-9210
Device Description
A sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Total Volume: 2000 Milliliter
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: 10885403222726
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: 50885403222724
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10885403222726
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case