Xcela; BioFlo; Vaxcel

GUDID H965PKM1938818S1

PICC Convenience Kit

NAVILYST MEDICAL, INC.

Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter

• Primary Device ID: H965PKM1938818S1
• NIH Device Record Key: 676eccf5-6124-46eb-9973-9b1bc21122a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xcela; BioFlo; Vaxcel
• Version Model Number: PKM1938818S
• Company DUNS: 809699023
• Company Name: NAVILYST MEDICAL, 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: false
• 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(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com

Device Dimensions

• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0
• Catheter Gauge: 4 French
• Length: 55 Centimeter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H965PKM1938818S0 [Primary]
HIBCC	H965PKM1938818S1 [Package]; Contains: H965PKM1938818S0; Package: BOX [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121990

FDA Product Code

• LJS: Catheter, intravascular, therapeutic, long-term greater than 30 days

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: 2019-09-27
• Device Publish Date: 2019-09-19

On-Brand Devices [Xcela; BioFlo; Vaxcel]

• H965PKM1938818S1: PICC Convenience Kit
• H96560M1837131: PICC Convenience Kit