AccessGUDID - DEVICE: N/A (00816576025572)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: G261
Commercial Distribution Status: In Commercial Distribution
Catalog Number: G261
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00816576025572
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: Leeds Acinetobacter Medium, 15x100mm Plate, 18ml. Leeds Acinetobacter Medium is a selective and differential medium intended for use as a plating technique to obtain a pure culture of Acinetobacter. The test is performed with a mixed population of microorganisms from a laboratory sample. Leeds Acinetobacter Medium is not intended for use in the identification of colonization with Acinetobacter to aid in the prevention and control of such bacteria in healthcare settings. Leeds Acinetobacter Medium is not intended to diagnose Acinetobacter infections, guide or monitor treatment for infections, or provide susceptibility results to antibiotics for which any strains of Acinetobacter are resistant. Sub-culturing is necessary for microorganism identification, susceptibility testing, and epidemiological typing.

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?
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
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: 15c49928-bc7b-4eab-a6a4-6662016da48e
Public Version Date: May 27, 2020
Public Version Number: 1
DI Record Publish Date: May 19, 2020