AccessGUDID - DEVICE: BD BBL™ Mueller Hinton Agar with 5% Sheep Blood (10382902219931)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ Mueller Hinton Agar with 5% Sheep Blood
Version or Model: 221993
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 221993
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 10382902219931
Issuing Agency: GS1
Commercial Distribution End Date: April 15, 2022
Device Count: 4
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: Plate Mueller Hinton Agar 5% SB 8 Ea

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 [?]
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: 150 Millimeter
Depth: 15 Millimeter

Device Record Status

Public Device Record Key: 50d73473-f8cf-4960-b5f9-512f0ca9a4ae
Public Version Date: October 13, 2023
Public Version Number: 3
DI Record Publish Date: December 21, 2016