AccessGUDID - DEVICE: AnaeroGRO (00816576024469)

GUDID

Device Identifier (DI) Information

Brand Name: AnaeroGRO
Version or Model: AG304
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AG304
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00816576024469
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: Brucella Agar with Hemin and Vitamin K 4Pak, Monoplate. Hardy Diagnostics AnaeroGRO™ Brucella Agar with Hemin and Vitamin K is recommended for use in the primary isolation, quantitation, and partial identification of obligately anaerobic microorganisms from clinical specimens. This non-selective medium is also suitable for the growth of aerobic and microaerophilic bacteria when incubated under the appropriate conditions.

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?
58688	Enriched agar culture medium IVD	An agar culture medium supplemented with nutrient-rich substances (e.g., blood, serum) intended to enhance the growth and isolation of fastidious microorganisms from a clinical specimen and/or culture isolate. It is typically used to cultivate microorganisms that would not otherwise grow on general-purpose agar medium.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KZI	Culture Media, Enriched

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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4287b3db-80f1-43ad-a148-30eff708179a
Public Version Date: May 21, 2020
Public Version Number: 1
DI Record Publish Date: May 13, 2020