AccessGUDID - DEVICE: NA (00816576020232)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: J212
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: J212
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00816576020232
Issuing Agency: GS1
Commercial Distribution End Date: October 25, 2021
Device Count: 10
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: CLED (Cystine Lactose Electrolyte Deficient): For the isolation, enumeration, and presumptive identification of urinary pathogens. Mueller Hinton: For antimicrobial susceptibility testing of non-fastidious bacteria.

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?
58639	Mueller-Hinton agar antimicrobial susceptibility culture medium IVD	A non-selective Mueller-Hinton agar culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on non-fastidious microorganisms in a clinical specimen and/or culture isolate.	Active	false
58585	Differential/selective agar culture medium IVD	An agar culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing on the same medium by appearance (e.g., colour, shape, growth pattern). It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K811646	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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 91fcb020-eb37-4cde-a505-db95d3182724
Public Version Date: October 26, 2021
Public Version Number: 4
DI Record Publish Date: September 01, 2016