POWERWAND™ XL 80701

GUDID 00859821006681

The POWERWAND™ XL Introducer with Extended Dwell Catheter, 4Fr x 10cm

ACCESS SCIENTIFIC, LLC

Peripheral vascular catheter

• Primary Device ID: 00859821006681
• NIH Device Record Key: de355e95-88f4-4579-b844-5a1f45c104f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POWERWAND™ XL
• Version Model Number: Alternate Site Kit 4Fr x 10cm
• Catalog Number: 80701
• Company DUNS: 079290879
• Company Name: ACCESS SCIENTIFIC, LLC
• 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

Device Dimensions

• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French
• Catheter Gauge: 4 French

Operating and Storage Conditions

• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 1004 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 1004 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859821006681 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-25
• Device Publish Date: 2018-09-24

On-Brand Devices [POWERWAND™ XL]

• 00859821006681: The POWERWAND™ XL Introducer with Extended Dwell Catheter, 4Fr x 10cm
• 10859821006800: POWERWAND XL Maximum Barrier Kit 4Fr x 10cm without Statlock and IV Extension Set
• 00859821006810: Pouch, PW XL 3FR 6cm (US) for Kit (40351)