CARDINAL HEALTH - ED3231-CM
Device Description
A fully-implantable device assembly intended to provide access to arteries/veins (excludes coronary and intracerebral circulation) for infusion (e.g., chemotherapeutic agents, blood transfusions) and/or drainage (e.g., blood). It consists of: 1) a subcutaneous chamber, with a self-sealing puncturable septum for percutaneous insertion of a hypodermic needle; and 2) an attached catheter which passes into the arteries/veins. It may consist of two chambers attached to a dual-lumen catheter for simultaneous infusion. It is made of metal [e.g., titanium (Ti)] and/or synthetic polymers (e.g., silicone); disposable devices associated with implantation may be included.
Environmental Conditions
No Data Available
Device Sizes
- 23G x 1" (0.6mm x 25mm)
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: MEG
Device Name: Syringe, Antistick
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: HO
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: 880.5860
Third Party Flag: Y
Medical Specialty: HO
Device IdentifiersDevice Id: 35019517065903
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15019517065909
Package Quantity: 50
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX
Device Id: 15019517065909
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: 55019517065907
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 35019517065903
Package Quantity: 8
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE