Capiox® Hardshell Reservoir - CX*SXRX
Device Description
A device intended to be integrated within an extracorporeal circuit to collect, store, and filter blood typically during a cardiopulmonary bypass procedure; it does not include additional functional components such as an oxygenator. It is typically a hardshell or soft, bag-like container with connectors designed to trap micro-particles and air bubbles for a period of time (e.g., 6 hours) and hold a reserve supply of blood; some types may also defoam. This is a single-use 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: DTZ
Device Name: Oxygenator, 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: Y
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.4350
Third Party Flag: N
Medical Specialty: CV
Device Identifiers
Device Id: 50699753450160
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00699753450165
Package Quantity: 4
Package Discontinue Date: 12/1/2018 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: 4 Piece Case
Device Id: 00699753450165
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
