AccessGUDID - DEVICE: Dimension® Flex® reagent cartridge BUN (00842768014116)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension® Flex® reagent cartridge BUN
Version or Model: 10444969
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DF21
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768014116
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Urea Nitrogen 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?
53587	Urea IVD, kit, enzyme spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen, using an enzyme spectrophotometry method. It is typically used as an indicator of kidney function and/or to differentiate between prerenal and postrenal azotemia.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
CDQ	UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN
JJE	ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: eb402e5a-07ed-4de0-b76a-8d8cc1ee1224
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016