POWERWAND

Basic Information

• Brand Name: POWERWAND
• Primary DI: 10859821006077
• Version / Model: 5Fr X 8cm
• Catalog Number: 92003
• Company Name: ACCESS SCIENTIFIC, LLC
• Labeler DUNS: 079290879
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 93013a26-d463-42c0-8d8c-668fa8bb92a8

Device Description

The POWERWAND. NanoPuncture Safety Introducer with Extended Dwell Catheter and Integral Needle Protection. *Fast-flash. *ZERO-EDGE Transitions. *Power Injectable

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYB	Introducer, Catheter	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40601	Peripheral vascular catheter	A sterile, thin, flexible tube intended to be inserted into the peripheral vasculature of a patient to enable short-term (< 30 days) intravascular access; it is not intended to be advanced to the central vasculature. It typically includes dedicated accessories to facilitate catheter introduction/placement and function (e.g., connectors, injection ports, stylet and/or wings for fixation). It may be used for blood sampling, monitoring of blood pressure, to administer fluids, medication and/or for the injection of contrast media. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30859821006071	GS1	Overpack	12	In Commercial Distribution
Package	20859821006074	GS1	Carton	10	In Commercial Distribution
Primary	10859821006077	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K131300	000

Device Sizes

Type	Value	Unit	Text
Length	8	Centimeter
Catheter Gauge	5	French

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Protect from direct contact with sun, water and humidity
• Type: Storage Environment Temperature
• Temperature Range: 32 – 104 Degrees Fahrenheit