AccessGUDID - DEVICE: Stratus CS Acute Care CCRP CalPak (00842768004476)

GUDID

Device Identifier (DI) Information

Brand Name: Stratus CS Acute Care CCRP CalPak
Version or Model: 10445067
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CCCRP-C
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768004476
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: The Stratus® CS Acute Care™ CardioPhase® High Sensitivity C-reactive Protein Calibrator (CCRP CalPak) is an in vitro diagnostic product intended to be used for calibration of the CCRP method 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):	Yes
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?
58768	C-reactive protein (CRP) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of C-reactive protein (CRP) in a clinical specimen, using a fluorescent immunoassay method [includes high-sensitivity CRP (hsCRP) types]. CRP is a marker associated with bacterial infection, inflammatory conditions, and cardiovascular disease.	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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 557b444e-9692-4c7e-bcaa-cf1df16a09f8
Public Version Date: June 10, 2022
Public Version Number: 6
DI Record Publish Date: September 24, 2016