Jelco

Jelco - 505311

A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: FOZ

Device Name: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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: 880.5200

Third Party Flag: Y

Medical Specialty: HO

Device Id: 55019315118614

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 35019315118610

Package Quantity: 200

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CARTON

Device Id: 35019315118610

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 15019315118616

Package Quantity: 50

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: BOX

Device Id: 15019315118616

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