AccessGUDID - DEVICE: BD BBL™ Selenite-F Broth (30382902210215)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ Selenite-F Broth
Version or Model: 221021
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 221021
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382902210215
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD BBL™ Selenite-F Broth, 8 mL, Carton of 100 size K tubes

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?
58687	Enriched broth culture medium IVD	A broth culture medium supplemented with nutrient-rich substances (e.g., blood, serum) intended to enhance the growth and isolation of fastidious microorganisms, from a clinical specimen and/or culture isolate. It is typically used to cultivate microorganisms that would not otherwise grow in a general-purpose broth medium.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSJ	CULTURE MEDIA, 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: 5b95f5f5-7267-4c40-bb56-c2a84530e8bf
Public Version Date: July 18, 2024
Public Version Number: 3
DI Record Publish Date: May 25, 2018