AccessGUDID - DEVICE: BD BBL™ Brain Heart Infusion Broth (30382902217788)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ Brain Heart Infusion Broth
Version or Model: 221778
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 221778
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382902217788
Issuing Agency: GS1
Commercial Distribution End Date: June 22, 2023
Device Count: 100
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: Tube BHI Broth 0.5 Ml 100 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?
58684	Differential/selective broth culture medium IVD	A broth culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing in the same medium. It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSC	CULTURE MEDIA, GENERAL NUTRIENT 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 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 0.5 Milliliter

Device Record Status

Public Device Record Key: 588572d3-85fb-4b41-9c2a-0f9e28ba3c0f
Public Version Date: November 01, 2023
Public Version Number: 2
DI Record Publish Date: May 25, 2018