ProFusion Therapeutic Infusion Needle

Basic Information

• Brand Name: ProFusion Therapeutic Infusion Needle
• Primary DI: 00827002584747
• Version / Model: PTIN-21-20.0
• Catalog Number: G58474
• Company Name: COOK BIODEVICE LLC
• Labeler DUNS: 080411091
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-04
• Public Version: 1
• Public Version Date: 2021-03-12
• Public Version Status: New
• Public Device Record Key: 2bec358b-0ea8-403e-8c48-57dca505bd90

Device Description

The ProFusion Needle is a stainless-steel needle with a trocar tip and distal sideports for infusion. The device also consists of a proximal plastic hub for Luer lock connections.

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: Yes
• 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
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17180	Subcutaneous infusion/injection port needle	A sterile, sharp bevel-edged, hollow tubular metal instrument intended to be attached to a syringe and designed for the therapeutic injection or infusion of medicinal substances directly beneath the skin layer. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002584747	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Needle Gauge	21	Gauge
Length	20.0	Centimeter