AccessGUDID - DEVICE: N/A (00816576026708)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: 7025
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 7025
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00816576026708
Issuing Agency: GS1
Commercial Distribution End Date: May 02, 2023
Device Count: 10
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: SIM (Sulfide, Indole, Motility) Medium, 6ml, 16x125mm tube, order by the package of 10 (Sulfide-Indole-Motility) For the identification of gram negative bacilli based on sulfide production, indole formation, and motility.

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?
58684	Differential/selective broth culture medium IVD	A broth 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 in the same medium. 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
JSD	Culture Media, Selective Broth

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 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 327a79e2-9388-4e82-9dfa-6d81eff186a3
Public Version Date: May 03, 2023
Public Version Number: 2
DI Record Publish Date: November 15, 2022