POWERWAND 92003

GUDID 30859821006071

The POWERWAND. NanoPuncture Safety Introducer with Extended Dwell Catheter and Integral Needle Protection. *Fast-flash. *ZERO-EDGE Transitions. *Power Injectable

ICU MEDICAL, INC.

Peripheral vascular catheter

• Primary Device ID: 30859821006071
• NIH Device Record Key: 93013a26-d463-42c0-8d8c-668fa8bb92a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POWERWAND
• Version Model Number: 5Fr X 8cm
• Catalog Number: 92003
• 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: 8 Centimeter
• Catheter Gauge: 5 French
• Length: 8 Centimeter
• Catheter Gauge: 5 French
• Length: 8 Centimeter
• Catheter Gauge: 5 French
• Length: 8 Centimeter
• Catheter Gauge: 5 French
• Length: 8 Centimeter
• Catheter Gauge: 5 French
• Length: 8 Centimeter
• Catheter Gauge: 5 French
• Length: 8 Centimeter
• Catheter Gauge: 5 French
• Length: 8 Centimeter
• Catheter Gauge: 5 French
• Length: 8 Centimeter
• Catheter Gauge: 5 French
• Length: 8 Centimeter
• Catheter Gauge: 5 French
• Length: 8 Centimeter
• Catheter Gauge: 5 French
• Length: 8 Centimeter
• Catheter Gauge: 5 French
• Length: 8 Centimeter
• Catheter Gauge: 5 French
• Length: 8 Centimeter
• Catheter Gauge: 5 French

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10859821006077 [Primary]
GS1	20859821006074 [Package]; Contains: 10859821006077; Package: Carton [10 Units]; In Commercial Distribution
GS1	30859821006071 [Package]; Contains: 20859821006074; Package: Overpack [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131300

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: 2016-09-09

On-Brand Devices [POWERWAND]

• 30859821006521: The POWERWAND-ED. Safety Introducer with Extended Dwell Catheter and Integral Needle Protection.
• 20859821006357: POWERWAND Max Barrier Kit 5Fr X 10cm
• 20859821006340: POWERWAND Quick Kit 5Fr X 10cm
• 30859821006088: The POWERWAND. NanoPuncture Safety Introducer with Extended Dwell Catheter and Integral Needle P
• 30859821006071: The POWERWAND. NanoPuncture Safety Introducer with Extended Dwell Catheter and Integral Needle P
• 20859821006067: The POWERWAND. NanoPuncture Safety Introducer with Extended Dwell Catheter and Integral Needle P
• 30859821006057: The POWERWAND. NanoPuncture Safety Introducer with Extended Dwell Catheter and Integral Needle P