PleurX Pleural Catheter and Starter Kit
PleurX - 50-7700
Device Description
A collection of sterile devices designed for catheterization of the pleural cavity and/or peritoneal cavity for drainage and/or aspiration of effusions, ascites, and/or air. It includes a pleural catheter and/or a peritoneal catheter typically with catheter introduction devices (e.g., needles, scalpel, tunneller). It also includes additional non-dedicated catheterization support devices (e.g., disposable scissors, gloves, dressings), drainage receptacle (e.g., collection bottle), and/or suction system regulator; it does not include any powered pumps or pharmaceuticals. This is a single-use device.
Environmental Conditions
- 25.00
- 20.00
Device Sizes
- Total Volume: 1000 Milliliter
- Catheter Gauge: 15.5 French
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DWM
Device Name: Apparatus, Suction, Patient Care
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: 870.5050
Third Party Flag: Y
Medical Specialty: CV
Device Identifiers
Device Id: 50885403231528
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10885403231520
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case
Device Id: 10885403231520
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: 20885403231527
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10885403231520
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Box