AccessGUDID - DEVICE: ADVIA Centaur® Gentamicin MCM (00630414527307)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA Centaur® Gentamicin MCM
Version or Model: 10322163
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5227559
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414527307
Issuing Agency: GS1
Commercial Distribution End Date: December 18, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Gentamicin Master Curve Material Set - CENTAUR - CONS

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?
55276	Gentamicin therapeutic drug monitoring IVD, control	A material which is used to verify the performance of 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: 04294a69-ceb0-4d0a-98ac-4fa7ff8aaf9d
Public Version Date: November 04, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2016