AccessGUDID - DEVICE: N/A (00819398028264)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: MV1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MV1
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398028264
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: MycoVue™ Slide Culture System, Potato Flake Agar, ready-to-use, includes cover slip and humidifier, 5 trays per box A ready-to-use slide culture system for the cultivation of fungi. Simplify your fungal slide cultures while saving money, reducing frustration, and eliminating preparation time. Desiccation is prevented with a built in humidity chamber and the culture can be incubated for long periods of time. Device fits conveniently on the microscope stage for easy observation without disturbing the fungal structures.

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):	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?
58685	Basic/simple nutrient agar culture medium IVD	A non-selective, non-differential nutrient agar culture medium containing intended to be used for the primary growth and isolation of typically non-fastidious microorganisms from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSG	Culture Media, Non-Selective And Non-Differential

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 164b1e27-c11d-4b6c-8e66-35148acb9c9b
Public Version Date: June 12, 2020
Public Version Number: 1
DI Record Publish Date: June 04, 2020