PowerStick

Basic Information

• Brand Name: PowerStick
• Primary DI: B3394010116100
• Version / Model: 40101-1610
• Catalog Number: 40101-1610
• Company Name: NEO MEDICAL INC.
• Labeler DUNS: 015510540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2023-08-02
• Public Version Status: Update
• Public Device Record Key: 9080b16e-529e-4b1e-ac84-459ffd89cc2a

Device Description

PowerStick 18ga x 10cm, Power Rated EPIV with MST

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
LJS	Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days	General Hospital	880.5970	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64573	Peripheral intravenous catheterization kit	A collection of devices intended for the introduction of an included peripheral vein cannula, often referred to as a catheter, to enable short-term (= 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. In addition to the cannula, it includes non-dedicated devices intended to support the procedure [e.g., tourniquet, swabs, dressings, disinfectants (e.g., alcohol), tape, gloves]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B3394010116105	HIBCC	Case	10	In Commercial Distribution
Primary	B3394010116100	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K071875	000

Device Sizes

Type	Value	Unit	Text
Pressure	300	Pound per Square Inch
Length	10.0	Centimeter
Catheter Gauge	4.0	French

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Away From Sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry