KIT 96552 BIO
Bio-Medicus™ - 96552
Device Description
A semi-rigid or rigid tube intended to be surgically inserted into an artery to serve as a channel for the extracorporeal transport of oxygenated blood to a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation. It is typically inserted using a compatible trocar blade which may be included. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- 1 x 8 Fr/10 Fr, 1 x 12 Fr/14 Fr, 1 x 16 Fr/18 Fr
- Guidewire Length: 100.0 Centimeter
- Guidewire Diameter: 0.965 Millimeter
- Needle Gauge: 18.0 Gauge
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DWF
Device Name: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
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: 870.4210
Third Party Flag: Y
Medical Specialty: CV
Device IdentifiersDevice Id: 20763000115993
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: 00763000115999
Device Type: Unit of Use
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