Celerity

GUDID H787471450

Celerity ECG Patient Cable Accessory

NAVILYST MEDICAL, INC.

Central venous catheter navigation system control unit Central venous catheter navigation system control unit Central venous catheter navigation system control unit Central venous catheter navigation system control unit Central venous catheter navigation system control unit Central venous catheter navigation system control unit Central venous catheter navigation system control unit Central venous catheter navigation system control unit Central venous catheter navigation system control unit Central venous catheter navigation system control unit Central venous catheter navigation system control unit Central venous catheter navigation system control unit Central venous catheter navigation system control unit Central venous catheter navigation system control unit Central venous catheter navigation system control unit Central venous catheter navigation system control unit Central venous catheter navigation system control unit Central venous catheter navigation system control unit

• Primary Device ID: H787471450
• NIH Device Record Key: b8de3fd1-6a2b-4c25-b5ab-abccae58401f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Celerity
• Version Model Number: H787471450
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H787471450 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142889

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-19

On-Brand Devices [Celerity]

• H787471470: Celerity Power Supply Cord Accessory
• H787471460: Celerity 7.2V Li Ion Battery Accessory
• H787471450: Celerity ECG Patient Cable Accessory
• H787471440: Celerity Remote Control Cable Accessory
• H787471430: Celerity Sterile Disposables (ECG Clip Cable and Cable Cover)
• H787471420: Celerity Non-Sterile Disposable (ECG Adhesive Electrodes & Prep Pads)
• H787471400: Celerity PICC Tip Confirmation System