Codonics Safe Label System® Administration Tool

Basic Information

• Brand Name: Codonics Safe Label System® Administration Tool
• Primary DI: 00814905020144
• Version / Model: 2.2.0
• Company Name: CODONICS INC.
• Labeler DUNS: 101533727
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 9f898dd3-d8c5-494c-8075-775e13d18c2e

Device Description

Administration Tool compatible with Codonics Safe Label System® 500i Point of Care Station

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BSZ	Gas-Machine, Anesthesia	Anesthesiology	868.5160	2

GMDN Terms

Code	Name	Definition	Implantable	Status
18169	Parenteral-nutrition management software	A software program intended to facilitate the management of the ordering, calculation, and preparation of customizable parenteral nutrition dosages for individual patients, according to physician prescriptions. It is used in conjunction with filling and compounding machines in hospital pharmacies and compounding centres to enable the automated and systematic production of parenteral nutrition dosages.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814905020144	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K101439	000