AccessGUDID - DEVICE: ADVIA Centaur® Systems, ACS:180® Systems GENT Calibrator (00630414527284)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA Centaur® Systems, ACS:180® Systems GENT Calibrator
Version or Model: 10322159
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5226110
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414527284
Issuing Agency: GS1
Commercial Distribution End Date: January 08, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Gentamicin - CENTAUR - CAL - 2x2x2mL

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?
55275	Gentamicin therapeutic drug monitoring IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and therapeutic monitoring of the antimicrobial drug gentamicin in a clinical specimen.	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
Special Storage Condition, Specify: store upright
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: 03832a37-7984-4e1d-b83c-4d204a91c817
Public Version Date: March 10, 2025
Public Version Number: 6
DI Record Publish Date: September 24, 2016