CerebroFlo EVD Catheter Set 37.550.501

GUDID 10866614000105

The CerebroFlo EVD Catheter is a polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through the drainage holes near the catheter's tip. The catheter is barium-sulfate impregnated to provide radiopacity. The CerebroFlo EVD Catheter is provided with a Stylette, Trocar, Barbed Leur Connector, Male Leur Cap, and a suture clip.

ARKIS BIOSCIENCES INC.

Intracerebral infusion/drainage catheter, short-term

• Primary Device ID: 10866614000105
• NIH Device Record Key: b3a38145-55be-4f7a-a6b1-f4cb46fdd2e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CerebroFlo EVD Catheter Set
• Version Model Number: 37.550.501
• Catalog Number: 37.550.501
• Company DUNS: 078846878
• Company Name: ARKIS BIOSCIENCES INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(844)247-5383
• Email: info@arkisbiosciences.com
• Phone: +1(844)247-5383
• Email: info@arkisbiosciences.com
• Phone: +1(844)247-5383
• Email: info@arkisbiosciences.com
• Phone: +1(844)247-5383
• Email: info@arkisbiosciences.com
• Phone: +1(844)247-5383
• Email: info@arkisbiosciences.com
• Phone: +1(844)247-5383
• Email: info@arkisbiosciences.com
• Phone: +1(844)247-5383
• Email: info@arkisbiosciences.com
• Phone: +1(844)247-5383
• Email: info@arkisbiosciences.com
• Phone: +1(844)247-5383
• Email: info@arkisbiosciences.com
• Phone: +1(844)247-5383
• Email: info@arkisbiosciences.com
• Phone: +1(844)247-5383
• Email: info@arkisbiosciences.com
• Phone: +1(844)247-5383
• Email: info@arkisbiosciences.com
• Phone: +1(844)247-5383
• Email: info@arkisbiosciences.com
• Phone: +1(844)247-5383
• Email: info@arkisbiosciences.com
• Phone: +1(844)247-5383
• Email: info@arkisbiosciences.com
• Phone: +1(844)247-5383
• Email: info@arkisbiosciences.com
• Phone: +1(844)247-5383
• Email: info@arkisbiosciences.com
• Phone: +1(844)247-5383
• Email: info@arkisbiosciences.com
• Phone: +1(844)247-5383
• Email: info@arkisbiosciences.com
• Phone: +1(844)247-5383
• Email: info@arkisbiosciences.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com

Device Dimensions

• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter
• Length: 35 Centimeter
• Outer Diameter: 3.3 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10866614000105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170599

FDA Product Code

• JXG: Shunt, Central Nervous System And Components

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-01
• Device Publish Date: 2019-10-24

On-Brand Devices [CerebroFlo EVD Catheter Set]

• 00866614000108: The CerebroFlo EVD Catheter is a polyurethane catheter for diverting cerebrospinal fluid (CSF) f
• 10866614000105: The CerebroFlo EVD Catheter is a polyurethane catheter for diverting cerebrospinal fluid (CSF) f