AccessGUDID - DEVICE: Dimension Vista® Flex® reagent cartridge DIGXN (00842768028335)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension Vista® Flex® reagent cartridge DIGXN
Version or Model: 10488927
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K6435
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768028335
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: LOCI Digoxin Flex® reagent cartridge, 200 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?
55326	Digoxin therapeutic drug monitoring IVD, kit, chemiluminescent assay	A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the cardiovascular drug digoxin in a clinical specimen, using a chemiluminescent method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXT	ENZYME IMMUNOASSAY, DIGOXIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K093441	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: 9eca6733-c697-497f-abf6-d3a5e6f2a777
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016