AccessGUDID - DEVICE: NA (00816576020225)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: J112
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: J112
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00816576020225
Issuing Agency: GS1
Commercial Distribution End Date: June 17, 2020
Device Count: 10
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: MRSA / VRE BIPLATE (Sect. 1: MH with 4% NaCl and Oxacillin 6mcg/ml; Sect II: BHI Agar with Vancomycin 6mcg/ml). For the detection of Methicillin Resistant Staphylococcus aureus and Vancomycin Resistant Enterococci.

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?
62106	Multiple formulation agar culture medium IVD	A combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of microorganisms from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSO	Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
JTZ	Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth

FDA Premarket Submission

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

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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 304cb67d-28e0-4524-8e90-a2e5dc7babc0
Public Version Date: June 18, 2020
Public Version Number: 3
DI Record Publish Date: September 01, 2016