NovaCath™ 221000

GUDID 10887709090368

NovaCath Integrated IV Catheter System 22G x 1.00in

ICU MEDICAL, INC.

Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula

• Primary Device ID: 10887709090368
• NIH Device Record Key: c2622909-6d93-49bd-ae4c-c411f1e05e8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NovaCath™
• Version Model Number: 221000
• Catalog Number: 221000
• Company DUNS: 118380146
• Company Name: ICU 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887709090361 [Primary]
GS1	10887709090368 [Package]; Contains: 00887709090361; Package: CS [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120839

FDA Product Code

• FOZ: Catheter, intravascular, therapeutic, short-term less 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: 2021-07-23
• Device Publish Date: 2021-07-15

On-Brand Devices [NovaCath™]

• 10887709121581: NovaCath Integrated IV Catheter System 22G x 0.75in
• 10887709090436: NovaCath Integrated IV Catheter System 24G x 0.75in
• 10887709090368: NovaCath Integrated IV Catheter System 22G x 1.00in