AccessGUDID - DEVICE: Stratus® CS Acute Care™ CKMB DilPak (00842768004513)

GUDID

Device Identifier (DI) Information

Brand Name: Stratus® CS Acute Care™ CKMB DilPak
Version or Model: 10445070
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CCKMB-D
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768004513
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™ CKMB Dilution Pak (CKMB DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ CKMB TestPak on the Stratus® CS analyzer for the measurement of samples with elevated CKMB levels.

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?
61385	Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of creatine kinase myocardial isoenzyme (CKMB) in a clinical specimen, using a fluorescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MMI	IMMUNOASSAY METHOD, TROPONIN SUBUNIT
DDR	MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL
JHX	FLUOROMETRIC METHOD, CPK OR ISOENZYMES
JIT	CALIBRATOR, SECONDARY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051650	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: 91a44c55-8edd-4a72-883a-327963a111cf
Public Version Date: November 19, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016