AccessGUDID - DEVICE: AnaeroGRO (00819398020114)

GUDID

Device Identifier (DI) Information

Brand Name: AnaeroGRO
Version or Model: AG24H
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AG24H
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398020114
Issuing Agency: GS1
Commercial Distribution End Date: February 05, 2024
Device Count: 20
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: Peptone Yeast Extract Glucose Broth, 16x125mm Tube with Hungate Septum Cap, 9ml. Hardy Diagnostics AnaeroGRO™ Peptone Yeast Extract Glucose Broth (PYG) is an enriched, non-selective medium recommended for the cultivation and biochemical identification of obligately anaerobic microorganisms. This medium is also suitable for the growth of anaerobic bacteria to be identified by gas liquid chromatography (GLC) analysis as outlined by the CDC.

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?
58687	Enriched broth culture medium IVD	A broth 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 in a general-purpose broth medium.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSC	Culture Media, General Nutrient 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: de8ae432-d459-464b-9faf-84b55639d973
Public Version Date: February 06, 2024
Public Version Number: 2
DI Record Publish Date: May 13, 2020