K-SHIELD ADVANTAGE SMALL VEIN INFUSION SET

Basic Information

• Brand Name: K-SHIELD ADVANTAGE SMALL VEIN INFUSION SET
• Primary DI: 00646311410482
• Version / Model: D3KA-19G
• Catalog Number: D3KA-19G
• Company Name: SB-KAWASUMI LABORATORIES, INC.
• Labeler DUNS: 690625850
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 5
• Public Version Date: 2024-01-30
• Public Version Status: Update
• Public Device Record Key: 9c9fd427-0a84-400f-bccb-cca9d57e1c19

Device Description

The K-Shield Advantage Small Vein Infusion Set with Antineedle Stick Protector is used to access a patient's vein for solution infusion. The device incorporates an integral active antineedle stick protector.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: 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
FPA	Set, Administration, Intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65416	Basic intravenous administration set, invasive	A collection of devices which includes a hypodermic needle (e.g., venous butterfly/scalp vein needle) intended to conduct fluids from an intravenous (IV) fluid container to a patient's venous system during administration; it may also be used for blood collection. In addition to the needle, the set may include tubing, connectors, chambers, clamps, gauze pads, alcohol pads and dressings; a bag/bottle may also be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00646311410482	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Needle Gauge	19	Gauge