Power V-Cath 4092-1660

GUDID B339409216605

4.0Fr x 60cm Single Lumen Power Rated PICC, 10cm Tearaway, Nitinol Tungsten 0.018 x 80cm marked wire, 7cm Safety GWI

NEO MEDICAL INC.

Peripherally-inserted central venous catheter

• Primary Device ID: B339409216605
• NIH Device Record Key: 863c09d5-c2d4-47b4-950f-ade2eedd5434
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Power V-Cath
• Version Model Number: 4092-1660
• Catalog Number: 4092-1660
• 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

Device Dimensions

• Length: 60 Centimeter
• Catheter Gauge: 4 French
• Length: 60 Centimeter
• Catheter Gauge: 4 French
• Length: 60 Centimeter
• Catheter Gauge: 4 French
• Length: 60 Centimeter
• Catheter Gauge: 4 French
• Length: 60 Centimeter
• Catheter Gauge: 4 French
• Length: 60 Centimeter
• Catheter Gauge: 4 French
• Length: 60 Centimeter
• Catheter Gauge: 4 French
• Length: 60 Centimeter
• Catheter Gauge: 4 French
• Length: 60 Centimeter
• Catheter Gauge: 4 French
• Length: 60 Centimeter
• Catheter Gauge: 4 French
• Length: 60 Centimeter
• Catheter Gauge: 4 French
• Length: 60 Centimeter
• Catheter Gauge: 4 French
• Length: 60 Centimeter
• Catheter Gauge: 4 French
• Length: 60 Centimeter
• Catheter Gauge: 4 French
• Length: 60 Centimeter
• Catheter Gauge: 4 French
• Length: 60 Centimeter
• Catheter Gauge: 4 French
• Length: 60 Centimeter
• Catheter Gauge: 4 French
• Length: 60 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B339409216600 [Primary]
HIBCC	B339409216605 [Package]; Contains: B339409216600; Package: Case [5 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 [Power V-Cath]

• B339509226605: 5.0Fr x 60cm Dual Lumen Power Rated PICC, 10cm Tearaway, Nitinol Tungsten 0.018 x 80cm marked wi
• B339509126600: 5.0Fr x 60cm Dual Lumen Power Rated PICC 5cm Tearaway, Nitinol 0.018 x 40cm wire, 7cm Safety GWI
• B339409216605: 4.0Fr x 60cm Single Lumen Power Rated PICC, 10cm Tearaway, Nitinol Tungsten 0.018 x 80cm marked
• B339409116605: 4.0Fr x 60cm Single Lumen Power Rated PICC 5cm Tearaway, Nitinol 0.018 x 40cm wire, 7cm Safety G