AccessGUDID - DEVICE: BD BBL™ Mueller Hinton Agar with 5% Sheep Blood (10382902218019)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ Mueller Hinton Agar with 5% Sheep Blood
Version or Model: 221801
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 221801
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 10382902218019
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD BBL™ Mueller Hinton Agar with 5% Sheep Blood, Pkg. of 24, 150 mm-style plates

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?
58640	Mueller-Hinton agar antimicrobial susceptibility culture medium IVD, sheep blood	A non-selective Mueller-Hinton culture medium containing defibrinated sheep blood intended to be used to perform diagnostic antimicrobial susceptibility testing on streptococci and other organisms requiring blood for growth that are isolated from a clinical specimen.	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 [?]
K960420	000

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
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: This way up
Special Storage Condition, Specify: Fragile, handle with care
Special Storage Condition, Specify: Keep away from light

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 150 Millimeter
Depth: 15 Millimeter

Device Record Status

Public Device Record Key: d9be56ae-844c-420b-af38-e36959c5d7a2
Public Version Date: May 20, 2025
Public Version Number: 5
DI Record Publish Date: December 21, 2016