AccessGUDID - DEVICE: ADVIA Centaur® GENT (00630414527277)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA Centaur® GENT
Version or Model: 10322154
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5223979
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414527277
Issuing Agency: GS1
Commercial Distribution End Date: October 15, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Gentamicin - CENTAUR - RGT - 50 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?
61017	Gentamicin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay	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 chemiluminescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LCD	ENZYME IMMUNOASSAY, GENTAMICIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K953020	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
Special Storage Condition, Specify: Store Upright, Protect from Light, Do not freeze, Resuspend

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1f5551b0-c112-417b-9064-adf87261754b
Public Version Date: November 04, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2016