AccessGUDID - DEVICE: Dimension® Flex® reagent cartridge GENT (00842768005336)

GUDID

Device Identifier (DI) Information

Brand Name: Dimension® Flex® reagent cartridge GENT
Version or Model: 10444927
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DF12
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00842768005336
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 005088112 *Terms of Use

Device Description: Gentamicin 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?
60845	Gentamicin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the antimicrobial drug gentamicin in a clinical specimen, using a nephelometry/turbidimetry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LCD	ENZYME IMMUNOASSAY, GENTAMICIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K962819	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: f8bd03bf-02a5-4a34-94a1-e8a75bf4fa6f
Public Version Date: November 18, 2021
Public Version Number: 5
DI Record Publish Date: September 24, 2016