AccessGUDID - DEVICE: Dimension® CKI/MBI CAL (00842768025549)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension® CKI/MBI CAL
Version or Model: 10464508
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DC32
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768025549
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: CKI/MBI Calibrator, 2x2x2mL

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?
44694	Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of creatine kinase myocardial isoenzyme (CKMB) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K081731	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 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cc937ed7-2ee2-478d-bdd4-fedf54ef9aa1
Public Version Date: November 18, 2021
Public Version Number: 4
DI Record Publish Date: September 24, 2016