AccessGUDID - DEVICE: Dimension® Flex® reagent cartridge CSAE (00842768005268)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension® Flex® reagent cartridge CSAE
Version or Model: 10444934
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: DF108
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768005268
Issuing Agency: GS1
Commercial Distribution End Date: September 01, 2024
Device Count: 4
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Cyclosporine Extended Range Flex® reagent cartridge, 80 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?
61886	Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the immunosuppressant drug cyclosporin A, or cyclosporine, in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MKW	CYCLOSPORINE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K052017	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: ddd40add-d210-45c1-b33e-dcb51cfd91b1
Public Version Date: October 02, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2016