AccessGUDID - DEVICE: N/A (00819398020510)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: C62
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C62
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398020510
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: Middlebrook 7H9 Broth with Tween® 80, 16x125mm Tube, 5ml. Hardy Diagnostics Middlebrook 7H9 Broth and Middlebrook 7H9 Broth with Tween® 80 are recommended for use in the cultivation of Mycobacterium spp. The media are also used for preparing dilutions of mycobacteria for antimicrobial testing.

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
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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 99872692-da49-40a2-8277-6ed60720dd85
Public Version Date: May 22, 2020
Public Version Number: 1
DI Record Publish Date: May 14, 2020