Stratus® CS STAT Fluorometric Analyzer Waste Container

Basic Information

• Brand Name: Stratus® CS STAT Fluorometric Analyzer Waste Container
• Primary DI: 00842768004599
• Version / Model: 10445078
• Catalog Number: CLINER
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 005088112
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2023-08-18
• Public Version Status: Update
• Public Device Record Key: a3dd0c49-009c-476f-b646-9049c0e28edf

Device Description

Stratus® CS STAT Fluorometric Analyzer Waste Container holds used rotors, tips, cups and paks and is an in vitro diagnostic product intended to be used on the Stratus® CS analyzer.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JHX	FLUOROMETRIC METHOD, CPK OR ISOENZYMES	Clinical Chemistry	862.1215	2

GMDN Terms

Code	Name	Definition	Implantable	Status
14426	Contaminated waste container	A container made of metal, hard plastic and/or cardboard designed for the safe deposit, collection and storage of contaminated and/or otherwise hazardous biological materials (e.g., waste products containing or having been in contact with human blood, sputum, urine and/or faeces). It is not intended to exclusively contain sharps or for in vitro diagnostic purposes. It is typically used with a disposable liner and has a self-closing lid. It is typically identified with a contaminated material symbol on its labelling. The contents will be sent to disposal usually by incineration. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842768004599	GS1
Unit of Use	00630414009919	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K984067	000