AccessGUDID - DEVICE: Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge (00842768013829)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension Mass Creatine Kinase MB Isoenzyme Flex reagent cartridge
Version or Model: 10444904
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RF420
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768013829
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 160 tests

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:	No
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?
47385	Multiple cardiac marker IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or a combination of cardiac markers in a clinical specimen, using an enzyme immunoassay (EIA) method. Cardiac markers to be assayed may include B-type natriuretic protein, D-dimer, creatine kinase myocardial isoenzyme (CKMB), myoglobin, myeloperoxidase (MPO), fatty acid binding protein (FABP), glycogen phosphorylase isoenzyme BB (GPBB), troponin I and/or troponin T.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JHY	COLORIMETRIC METHOD, CPK OR ISOENZYMES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K970343	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: b28c4327-1044-4aff-83ba-29cd624ff3be
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016