Infusion Safety Products, Inc.

Basic Information

• Brand Name: Infusion Safety Products, Inc.
• Primary DI: 00856673008191
• Version / Model: ISP2015Y
• Company Name: INFUSION SAFETY PRODUCTS, INC.
• Labeler DUNS: 024502047
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-20
• Public Version: 3
• Public Version Date: 2020-02-26
• Public Version Status: Update
• Public Device Record Key: 3ec21e3d-693d-43aa-9d10-f3207f5db0dc

Device Description

20ga x 1.50" RA, Non-Coring Safety Huber Needle Infusion Set with 8.5" tubing and a "Y" port with a non-vented cap, Latex Free, Non-DEHP Tubing, Lipid Resistant, Rated to 300 psi, Approx. Priming Volume .35cc

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: No
• 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
PTI	Non-Coring (Huber) Needle	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17701	Vascular port administration set	A collection of devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system via a previously implanted injection/infusion port. It typically includes a noncoring needle designed with a lateral hole (side-hole), tubing, connectors, chambers, clamps and may include an injection placement aid. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856673008191	GS1
Package	10856673008198	GS1		25	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K170881	000