AccessGUDID - DEVICE: BD Difco™ Wilkins-Chalgren Agar (00382902180517)

GUDID

Device Identifier (DI) Information

Brand Name: BD Difco™ Wilkins-Chalgren Agar
Version or Model: 218051
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 218051
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382902180517
Issuing Agency: GS1
Commercial Distribution End Date: May 07, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD Difco™ Wilkins-Chalgren 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?
61686	Anaerobic-microorganism antimicrobial susceptibility culture medium IVD	A non-selective culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing of anaerobic microorganisms isolated from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSO	CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON AGAR

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 500 Gram

Device Record Status

Public Device Record Key: 1cadb0fe-a282-43b0-bab2-ca3411f88d10
Public Version Date: May 08, 2025
Public Version Number: 4
DI Record Publish Date: July 07, 2016