AccessGUDID - DEVICE: HardyDisk™ (00816576020744)

GUDID

Device Identifier (DI) Information

Brand Name: HardyDisk™
Version or Model: Z8611
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z8611
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00816576020744
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: Levofloxacin 5μg (LVX5) HardyDisk™ AST Disks are used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure (Kirby-Bauer) of rapidly growing and certain fastidious bacterial pathogens. Standardized methods for agar diffusion testing have been described for Enterobacteriaceae, Staphylococcus spp., Pseudomonas spp., Acinetobacter spp., Listeria monocytogenes, Enterococcus spp., and by modified procedures, Haemophilus spp., Neisseria gonorrhoeae, N. meningitidis and Streptococcus spp., including Streptococcus pneumoniae.

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:	Yes
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?
59139	Levofloxacin susceptibility testing disc IVD	A susceptibility testing disc impregnated with a defined amount of the antimicrobial levofloxacin, intended to be used to determine the antimicrobial susceptibility of a specific microorganism isolated from a clinical specimen by culture, using a disc diffusion method.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JTN	Susceptibility Test Discs, Antimicrobial

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K002664	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 -20 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f8bb7e9c-7160-436c-bcd2-6e9679d90664
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 02, 2016