AccessGUDID - DEVICE: Dimension® Flex® reagent cartridge TBI (00842768020544)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension® Flex® reagent cartridge TBI
Version or Model: 10444957
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DF167
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768020544
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 8
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Total Bilirubin Flex® reagent cartridge, 480 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?
53229	Total bilirubin IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total bilirubin in a clinical specimen, using a spectrophotometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CIG	DIAZO COLORIMETRY, BILIRUBIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060628	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: 6ca9dc3e-2277-4c0c-a861-e9dfd9819c6f
Public Version Date: July 06, 2023
Public Version Number: 6
DI Record Publish Date: September 24, 2016