AccessGUDID - DEVICE: Dimension® Flex® reagent cartridge T4 (00842768005626)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension® Flex® reagent cartridge T4
Version or Model: 10444908
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DF65
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768005626
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Thyroxine Flex® reagent cartridge, 120 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?
58323	Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of total thyroxine (TT4) in a clinical specimen, using an enzyme immunoassay (EIA) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CIG	DIAZO COLORIMETRY, BILIRUBIN
KLI	Enzyme immunoassay, non-radiolabeled, total thyroxine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K862359	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: 2dda3510-f6e1-4b13-a6f8-d041abb684b7
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016