AccessGUDID - DEVICE: BD BBL™ Phenol Red Broth Base (30382902218976)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ Phenol Red Broth Base
Version or Model: 221897
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 221897
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382902218976
Issuing Agency: GS1
Commercial Distribution End Date: July 28, 2021
Device Count: 10
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD BBL™ Phenol Red Broth Base

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?
55776	Organic solvent metabolite IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple metabolites/biomarkers (e.g., phenol) associated with occupational or environmental exposure to volatile organic solvents [e.g., benzene, styrene, toluene, xylene] in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSG	CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

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
Total Volume: 8 Milliliter

Device Record Status

Public Device Record Key: 47c0bfa7-a541-4d14-a6fc-fbb2804fe736
Public Version Date: November 10, 2023
Public Version Number: 3
DI Record Publish Date: May 25, 2018