POWERWAND XL 94122

GUDID 30859821006101

The POWERWAND XL Introducer with Extended Dwell Catheter. *Power Injectable. *ZERO-EDGE transitions. *Radiopaque

ICU MEDICAL, INC.

Peripheral vascular catheter

• Primary Device ID: 30859821006101
• NIH Device Record Key: 2a587ed0-da34-4f58-b699-c492c3a89b09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POWERWAND XL
• Version Model Number: 3Fr x 6cm
• Catalog Number: 94122
• 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-858-259-8333
• Email: cs@accessscientific.com
• Phone: 1-858-259-8333
• Email: cs@accessscientific.com
• Phone: 1-858-259-8333
• Email: cs@accessscientific.com
• Phone: 1-858-259-8333
• Email: cs@accessscientific.com
• Phone: 1-858-259-8333
• Email: cs@accessscientific.com
• Phone: 1-858-259-8333
• Email: cs@accessscientific.com
• Phone: 1-858-259-8333
• Email: cs@accessscientific.com
• Phone: 1-858-259-8333
• Email: cs@accessscientific.com
• Phone: 1-858-259-8333
• Email: cs@accessscientific.com
• Phone: 1-858-259-8333
• Email: cs@accessscientific.com
• Phone: 1-858-259-8333
• Email: cs@accessscientific.com
• Phone: 1-858-259-8333
• Email: cs@accessscientific.com
• Phone: 1-858-259-8333
• Email: cs@accessscientific.com
• Phone: 1-858-259-8333
• Email: cs@accessscientific.com

Device Dimensions

• Length: 6 Centimeter
• Catheter Gauge: 3 French
• Length: 6 Centimeter
• Catheter Gauge: 3 French
• Length: 6 Centimeter
• Catheter Gauge: 3 French
• Length: 6 Centimeter
• Catheter Gauge: 3 French
• Length: 6 Centimeter
• Catheter Gauge: 3 French
• Length: 6 Centimeter
• Catheter Gauge: 3 French
• Length: 6 Centimeter
• Catheter Gauge: 3 French
• Length: 6 Centimeter
• Catheter Gauge: 3 French
• Length: 6 Centimeter
• Catheter Gauge: 3 French
• Length: 6 Centimeter
• Catheter Gauge: 3 French
• Length: 6 Centimeter
• Catheter Gauge: 3 French
• Length: 6 Centimeter
• Catheter Gauge: 3 French
• Length: 6 Centimeter
• Catheter Gauge: 3 French
• Length: 6 Centimeter
• Catheter Gauge: 3 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10859821006107 [Primary]
GS1	20859821006104 [Package]; Contains: 10859821006107; Package: Carton [10 Units]; In Commercial Distribution
GS1	30859821006101 [Package]; Contains: 20859821006104; Package: Overpack [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162322

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2025-03-18
• Device Publish Date: 2017-02-28

On-Brand Devices [POWERWAND XL]

• 20859821006470: POWERWAND XL Quick Kit 3Fr X 6cm
• 30859821006101: The POWERWAND XL Introducer with Extended Dwell Catheter. *Power Injectable. *ZERO-EDGE transiti