AccessGUDID - DEVICE: Dimension® CSAE Calibrator (00842768018213)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension® CSAE Calibrator
Version or Model: 10445004
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: DC108A
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768018213
Issuing Agency: GS1
Commercial Distribution End Date: September 01, 2024
Device Count: 6
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Cyclosporine Extended Range Calibrator, 1x5x2mL

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?
55439	Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and therapeutic monitoring of the immunosuppressant drug cyclosporin A or cyclosporine in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DLJ	CALIBRATORS, DRUG SPECIFIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K061503	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 -70 and -20 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a3f9f716-66fc-4d34-b682-cdbcb1fef189
Public Version Date: October 02, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2016