POWERWAND 72627

GUDID 00859821006674

POWERWAND™ ED Quick Kit 3FR 6cm

ACCESS SCIENTIFIC, LLC

Peripheral vascular catheter

• Primary Device ID: 00859821006674
• NIH Device Record Key: 1cc80955-5e24-4f47-84a2-af9533671f26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POWERWAND
• Version Model Number: Quick Kit 3Fr X 6cm
• Catalog Number: 72627
• 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

• Length: 6 Centimeter
• Length: 6 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859821006674 [Primary]
GS1	10859821006671 [Package]; Package: Carton [10 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-27

On-Brand Devices [POWERWAND]

• 00859821006674: POWERWAND™ ED Quick Kit 3FR 6cm
• 20859821006456: Deluxe Dressing Change Kit W/Zpad
• 20859821006388: POWERWAND Dressing Change Kit with Zpad
• 20859821006371: POWERWAND Dressing Change Kit with StatLock
• 10859821006756: Dressing Change Kit w/Statlock
• 00859821006780: POWERWAND™ ED 3Fr x 6cm (Custom)
• 10859821006794: POWERWAND™ ED Quick Kit 3Fr x 6cm (Custom)