AccessGUDID - DEVICE: BD BBL™ Mueller Hinton II Agar (10382902211775)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ Mueller Hinton II Agar
Version or Model: 221177
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 221177
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 10382902211775
Issuing Agency: GS1
Commercial Distribution End Date: March 10, 2022
Device Count: 10
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD BBL™ Mueller Hinton II Agar

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):	Yes
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?
58639	Mueller-Hinton agar antimicrobial susceptibility culture medium IVD	A non-selective Mueller-Hinton agar 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: 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
Outer Diameter: 100 Millimeter
Depth: 15 Millimeter

Device Record Status

Public Device Record Key: 9fb7acad-ba55-4220-9999-df9b73b44fcb
Public Version Date: October 11, 2023
Public Version Number: 3
DI Record Publish Date: December 21, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30382902211779	2	10382902211775	2022-03-10	Not in Commercial Distribution	Shelfpack
60382902211770	400	30382902211779	2022-03-10	Not in Commercial Distribution	US pallet