AccessGUDID - DEVICE: N/A (00819398024624)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: Y101
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: Y101
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398024624
Issuing Agency: GS1
Commercial Distribution End Date: October 25, 2021
Device Count: 20
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: Purple Broth with Adonitol, 10mL, 16x125mm tube, 20 tubes/box For the differentiation of microorganisms based on acidification of carbohydrates or other compounds.

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
JSI	Culture Media, Selective And Differential

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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 757a1660-d967-48bf-9327-ac84e8d936b0
Public Version Date: October 26, 2021
Public Version Number: 2
DI Record Publish Date: June 08, 2020