AccessGUDID - DEVICE: HardyCHROM™ (00816576025770)

GUDID

Device Identifier (DI) Information

Brand Name: HardyCHROM™
Version or Model: G323
Commercial Distribution Status: In Commercial Distribution
Catalog Number: G323
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00816576025770
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: HardyCHROM™ CRE, 15x100mm Plate, 18ml HardyCHROM™ CRE is a selective and differential chromogenic agar medium intended for the qualitative and presumptive detection from stool specimens of Escherichia coli that are non-susceptible to carbapenems as pink colonies and KES (Klebsiella aerogenes, Klebsiella oxytoca,Klebsiella pneumoniae, Enterobacter cloacae complex, and Serratia marcescens) that are non-susceptible to carbapenems as blue colonies.

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?
61275	Multiple bacteria carbapenemase production IVD, kit, chromogenic	A collection of reagents and other associated materials intended to be used for the qualitative detection of cabapenemase enzyme production by a microorganism isolated from a clinical specimen by culture, using a chromogenic method.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190553	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: c78d3510-f1a5-45c0-9c3c-e9e8f5ba3137
Public Version Date: October 29, 2019
Public Version Number: 1
DI Record Publish Date: October 21, 2019