AccessGUDID - DEVICE: Stratus® CS STAT Fluorometric Analyzer Pipette Tips (00842768004681)

GUDID

Device Identifier (DI) Information

Brand Name: Stratus® CS STAT Fluorometric Analyzer Pipette Tips
Version or Model: 10445089
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CTIP
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768004681
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1920
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Stratus® CS STAT Fluorometric Analyzer Pipette Tips are in vitro diagnostics devices which are 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?
16822	Pipette tip	A device formed as a pointed cylindrical tip that is attached to the dispensing opening of a pipette or a dispenser and where the required volume of liquid is drawn for delivery to the target receptacle. It may show a gradient scale or not and is usually made of plastic but may also be made of glass. This is a single-use 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
Storage Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6ff1dc20-c1f5-4bb2-b430-8434d3148c75
Public Version Date: November 19, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016