AccessGUDID - DEVICE: Stratus® CS STAT Fluorometric Analyzer Sample Cups (00842768004551)

GUDID

Device Identifier (DI) Information

Brand Name: Stratus® CS STAT Fluorometric Analyzer Sample Cups
Version or Model: 10445074
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CCUPS
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768004551
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Stratus® CS STAT Fluorometric Analyzer sample cups are used to introduce quality control (QC) material or previously centrifuged plasma for processing.

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?
46237	General laboratory container, single-use	A container (e.g., test tube, bottle, cup, assay tray with large wells) intended to be used as a non-dedicated receptacle to hold consumable laboratory substances (e.g., reagents, buffers), specimens, and other materials associated with procedures in the laboratory; it is not intended for in vitro diagnostic procedures. It is typically made of plastic or glass and may be used on the benchtop for manual procedures, or on-board automated liquid handling instruments or analysers. 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: ac4597cf-050f-471a-b98d-9e16d9594b95
Public Version Date: November 03, 2023
Public Version Number: 7
DI Record Publish Date: September 24, 2016