AccessGUDID - DEVICE: T8006 Sensititre™ Cation Adjusted Mueller-Hinton w/ TES w/ OADC (00848838090981)

GUDID

Device Identifier (DI) Information

Brand Name: T8006 Sensititre™ Cation Adjusted Mueller-Hinton w/ TES w/ OADC
Version or Model: T8006 Sensititre™ Cation Adjusted Mueller-Hinton w/ TES w/ OADC
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: REMEL, INC.

Primary DI Number: 00848838090981
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 065769564 *Terms of Use

Device Description: No description.

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?
58641	Mueller-Hinton broth antimicrobial susceptibility culture medium IVD	A non-selective Mueller-Hinton broth culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on non-fastidious microorganisms in a clinical specimen and/or culture isolate.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JTZ	Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: fd16cba1-4560-4bc8-b233-dda6c2c59e10
Public Version Date: January 24, 2025
Public Version Number: 1
DI Record Publish Date: January 16, 2025