Chemosite

Basic Information

• Brand Name: Chemosite
• Primary DI: 10884521099296
• Version / Model: 120066
• Catalog Number: 120066
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-28
• Public Version: 4
• Public Version Date: 2021-05-17
• Public Version Status: Update
• Public Device Record Key: 42f2f2b6-d32f-4832-9976-ebe0021e1128
• Distribution End Date: 2020-11-03

Device Description

Venous Access System,120020;120039

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: MR Conditional
• 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
LJS	Catheter,intravascular,therapeutic,long-term greater than 30 days	General Hospital	880.5970	2

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	10884521099296	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K961856	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	1.0	Millimeter
Outer Diameter	2.8	Millimeter