Infusion Safety Products, Inc.

Basic Information

• Brand Name: Infusion Safety Products, Inc.
• Primary DI: 08566730080016
• Version / Model: ISP195
• Company Name: INFUSION SAFETY PRODUCTS, INC.
• Labeler DUNS: 024502047
• Distribution Status: Not 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: aa82b1d3-451b-4bc9-ae26-32d3829d166a
• Distribution End Date: 2020-02-21

Device Description

19ga x .50" RA, Non-Coring Safety Huber Needle Infusion Set with 7.5" tubing, Latex Free, Non-DEHP Tubing, Lipid Resistant, Rated to 300 psi, Approx. Priming Volume .25cc

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
Package	28566730080010	GS1		25	Not in Commercial Distribution	2020-02-21
Primary	08566730080016	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K170881	000