INTERMITTENT INJECTION SITE

Basic Information

• Brand Name: INTERMITTENT INJECTION SITE
• Primary DI: 00646311500015
• Version / Model: INT-01
• Catalog Number: INT-01
• 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: 2024-02-02
• Public Version Status: Update
• Public Device Record Key: f4395270-414d-4a04-a0fd-58186115a31b

Device Description

"The product is a simple injection/aspiration port which will be sold by itself. It terminates in a male luer taper which can be mated with any femail luer tapered lumen in a device, such as a catheter, communicating with blood or other body fluids. The port occludes the lumen of the catheter or other device. It also provides a latex septum for injection of fluids, including medication, or for aspiration of blood or fluids for testing, ETC. The septum is no-slitted. The Product is discarded when the main device is changed. This product comes with a luer protector cap which is removed and discarded before attaching the port to the catheter or device. This product is not specifically designed for use in hemodialysis systems."

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
FOZ	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12170	Intravenous administration tubing extension set	A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00646311500015	GS1

Customer Contacts

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