AccessGUDID - DEVICE: N/A (00819398023986)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: U98
Commercial Distribution Status: In Commercial Distribution
Catalog Number: U98
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398023986
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: Middlebrook OADC, 100ml, 6 ounce bottle, by Hardy Diagnostics, each A supplement for Middlebrook culture media

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:	No
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?
62160	Culture medium nutrient supplement IVD	A formulation of non-selective supplements containing nutrients e.g., (amino acids, sugars, minerals) or other additives (e.g., serum, haemoglobin) intend to enrich a culture medium to sustain and/or enhance the growth or isolation of a specific target microbial species from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSK	Supplement, Culture Media

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
Special Storage Condition, Specify: Protect media from light

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6ff8024e-0356-4202-b847-f2e780d6687d
Public Version Date: June 15, 2020
Public Version Number: 1
DI Record Publish Date: June 05, 2020