AccessGUDID - DEVICE: Dimension® TNI CAL (00842768022074)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension® TNI CAL
Version or Model: 10464336
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RC621
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768022074
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: LOCI Cardiac Troponin I Calibrator, 2x5x2mL

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):	Yes
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?
54011	Troponin I 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 troponin I in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIT	CALIBRATOR, SECONDARY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K081683	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: 7d8a4c66-5752-4098-9a34-e87b6d80d2b5
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016