POWERWAND 71697

GUDID 20859821006371

POWERWAND Dressing Change Kit with StatLock

ACCESS SCIENTIFIC, LLC

Wearable percutaneous catheter/tube holder

• Primary Device ID: 20859821006371
• NIH Device Record Key: 6ba743ef-d3b2-4f35-b153-4b99dca2d9ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POWERWAND
• Version Model Number: Dressing Change Kit with StatLock
• Catalog Number: 71697
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Protect from direct contact with sun, water and humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10859821006374 [Primary]
GS1	20859821006371 [Package]; Contains: 10859821006374; Package: Carton [20 Units]; In Commercial Distribution

FDA Product Code

• OXQ: Dressing Change Tray

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-07-22
• Device Publish Date: 2016-09-09

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)