AccessGUDID - DEVICE: Dimension Vista® Flex® reagent cartridge MBI (00842768027918)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension Vista® Flex® reagent cartridge MBI
Version or Model: 10464339
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K3032
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768027918
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 120 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
JHS	DIFFERENTIAL RATE KINETIC METHOD, CPK OR ISOENZYMES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K083465	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: 0627e295-7304-4458-bd64-1fb8693ad289
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016