POWERWAND™ XL

Basic Information

• Brand Name: POWERWAND™ XL
• Primary DI: 00859821006681
• Version / Model: Alternate Site Kit 4Fr x 10cm
• Catalog Number: 80701
• Company Name: ACCESS SCIENTIFIC, LLC
• Labeler DUNS: 079290879
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-24
• Public Version: 1
• Public Version Date: 2018-10-25
• Public Version Status: New
• Public Device Record Key: de355e95-88f4-4579-b844-5a1f45c104f2

Device Description

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

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
Primary	00859821006681	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K131300	000

Device Sizes

Type	Value	Unit	Text
Pressure	325	Pound per Square Inch
Needle Gauge	21	Gauge
Length	10	Centimeter
Catheter Gauge	4	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 – 1004 Degrees Fahrenheit