AccessGUDID - DEVICE: Stratus® CS STAT Fluorometric Analyzer Waste Container (00842768004599)

GUDID

Device Identifier (DI) Information

Brand Name: Stratus® CS STAT Fluorometric Analyzer Waste Container
Version or Model: 10445078
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CLINER
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768004599
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JHX	FLUOROMETRIC METHOD, CPK OR ISOENZYMES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K984067	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a3dd0c49-009c-476f-b646-9049c0e28edf
Public Version Date: August 18, 2023
Public Version Number: 5
DI Record Publish Date: September 24, 2016