PowerStick 40101-1610

GUDID B3394010116105

PowerStick 18ga x 10cm, Power Rated EPIV with MST

NEO MEDICAL INC.

Peripheral vascular catheter

• Primary Device ID: B3394010116105
• NIH Device Record Key: 9080b16e-529e-4b1e-ac84-459ffd89cc2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PowerStick
• Version Model Number: 40101-1610
• Catalog Number: 40101-1610
• Company DUNS: 015510540
• Company Name: NEO MEDICAL INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com
• Phone: 888-450-3334
• Email: support@neomedicalinc.com

Device Dimensions

• Pressure: 300 Pound per Square Inch
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Pressure: 300 Pound per Square Inch
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Pressure: 300 Pound per Square Inch
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Pressure: 300 Pound per Square Inch
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Pressure: 300 Pound per Square Inch
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Pressure: 300 Pound per Square Inch
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Pressure: 300 Pound per Square Inch
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Pressure: 300 Pound per Square Inch
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Pressure: 300 Pound per Square Inch
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Pressure: 300 Pound per Square Inch
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Pressure: 300 Pound per Square Inch
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Pressure: 300 Pound per Square Inch
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Pressure: 300 Pound per Square Inch
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Pressure: 300 Pound per Square Inch
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Pressure: 300 Pound per Square Inch
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Pressure: 300 Pound per Square Inch
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Pressure: 300 Pound per Square Inch
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Pressure: 300 Pound per Square Inch
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Pressure: 300 Pound per Square Inch
• Length: 10 Centimeter
• Catheter Gauge: 4 French
• Pressure: 300 Pound per Square Inch
• Length: 10 Centimeter
• Catheter Gauge: 4 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away From Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B3394010116100 [Primary]
HIBCC	B3394010116105 [Package]; Contains: B3394010116100; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071875

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [PowerStick]

• B3394012116185: PowerStick 18ga x 18cm, Power Rated EPIV with MST
• B3394010116185: PowerStick 18ga x 18cm, Power Rated EPIV with Nitinol MST
• B3394010116105: PowerStick 18ga x 10cm, Power Rated EPIV with MST
• B3394010116085: PowerStick 18ga x 8cm, Power Rated EPIV with MST
• B3393012116185: PowerStick 20ga x 18cm, Power Rated EPIV with MST
• B3393010116185: PowerStick 20ga x 18cm, Power Rated EPIV with Nitinol MST
• B3393010116105: PowerStick 20ga x 10cm, Power Rated EPIV with MST
• B3393010116085: PowerStick 20ga x 8cm, Power Rated EPIV with MST