AccessGUDID - DEVICE: HardyCHROM™ (00816576023097)

GUDID

Device Identifier (DI) Information

Brand Name: HardyCHROM™
Version or Model: G321
Commercial Distribution Status: In Commercial Distribution
Catalog Number: G321
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00816576023097
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: HardyCHROM™ ESBL A chromogenic medium for use as a primary screening method for the detection and differentiation of Extended-Spectrum Beta-Lactamase producing Enterobacteriaciae. Some ingredients are very light sensitive. Store and incubate in the dark.

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?
58600	ESBL Enterobacteriaceae agar culture medium IVD, chromogenic	A selective and/or differential agar culture medium containing chromogenic substrates intended to be used to screen for extended spectrum beta-lactamase (ESBL) producing Enterobacteriaceae in a clinical specimen.	Obsolete	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 [?]
K160512	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: d785fecf-87f5-43a8-a788-f6277347508b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: March 28, 2017