AccessGUDID - DEVICE: MicroScan (15099590772741)

GUDID

Device Identifier (DI) Information

Brand Name: MicroScan
Version or Model: V5.00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C90679, C90680
Company Name: Beckman Coulter, Inc.

Primary DI Number: 15099590772741
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008254708 *Terms of Use

Device Description: LabPro V5.0 Panel Update 10 (US), Electronic - C90679; DVD, LabPro V5.0 Panel Update 10 (US) - C90680

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):	Yes
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?
56747	Microorganism identification/antimicrobial-susceptibility analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the identification of bacteria and/or yeast isolated from clinical specimens and for the determination of their antimicrobial susceptibility profile using morphology, substrate utilization and/or biochemical reactivity and by monitoring growth rates and/or determining endpoint growth, against a range of antimicrobials. Growth detection technology used may include immunoassay, colorimetry, fluorimetry, chromatography and/or carbon dioxide production.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201405	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 167ff431-fe4e-4ca0-a2d3-3478b445af2e
Public Version Date: November 17, 2022
Public Version Number: 3
DI Record Publish Date: August 01, 2022