ARTERIAL WAND 96001

GUDID 20859821006692

The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology

ACCESS SCIENTIFIC, LLC

Peripheral vascular catheter

• Primary Device ID: 20859821006692
• NIH Device Record Key: 20dd937d-639a-4b97-8d14-05129c601527
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARTERIAL WAND
• Version Model Number: 3Fr x 5cm
• Catalog Number: 96001
• 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: 1-858-259-8334
• Email: cs@accessscientific.com

Device Dimensions

• Catheter Length: 5 Centimeter
• Catheter Length: 5 Centimeter
• Catheter Length: 5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859821006698 [Primary]
GS1	10859821006695 [Package]; Contains: 00859821006698; Package: [10 Units]; In Commercial Distribution
GS1	20859821006692 [Package]; Contains: 10859821006695; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181563

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: 2018-11-12
• Device Publish Date: 2018-10-11

Devices Manufactured by ACCESS SCIENTIFIC, LLC

• 10859821006794 - POWERWAND: 2024-03-20 POWERWAND™ ED Quick Kit 3Fr x 6cm (Custom)
• 00859821006810 - POWERWAND™ XL: 2024-03-20 Pouch, PW XL 3FR 6cm (US) for Kit (40351)
• 10859821006800 - POWERWAND™ XL: 2020-10-08 POWERWAND XL Maximum Barrier Kit 4Fr x 10cm without Statlock and IV Extension Set
• 00859821006780 - POWERWAND: 2020-04-28 POWERWAND™ ED 3Fr x 6cm (Custom)
• 10859821006756 - POWERWAND: 2019-12-20 Dressing Change Kit w/Statlock
• 10859821006763 - POWERWAND™ XL Alternate Site with Needle Guide Kit: 2019-12-13 POWERWAND™ XL Alternate Site with Needle Guide Kit
• 20859821006708 - CVC WAND: 2019-12-09 The CVC WAND Safety Introducer with Valved Peelable Sheath
• 20859821006715 - CVC WAND XL: 2019-12-09 The CVC WAND Safety Introducer with Valved Peelable Sheath