AccessGUDID - DEVICE: N/A (00819398023054)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: R10
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: R10
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398023054
Issuing Agency: GS1
Commercial Distribution End Date: January 04, 2024
Device Count: 20
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: BHI (Brain Heart Infusion) Broth, 0.5ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 (Brain Heart Infusion Broth) For the cultivation of microorganisms.

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?
58586	Basic/simple nutrient broth culture medium IVD	A non-selective, non-differential nutrient broth culture medium intended to be used to for the primary growth and isolation of typically non-fastidious microorganisms from a clinical specimen.	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
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: 1124ed40-214a-48ef-a40d-9fbac6761b82
Public Version Date: January 05, 2024
Public Version Number: 2
DI Record Publish Date: June 04, 2020