AccessGUDID - DEVICE: BD BBL™ Brain Heart Infusion (30382902218129)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ Brain Heart Infusion
Version or Model: 221812
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 221812
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382902218129
Issuing Agency: GS1
Commercial Distribution End Date: June 22, 2023
Device Count: 10
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: Tube BHI Broth 5Ml 10 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?
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
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: 5 Milliliter

Device Record Status

Public Device Record Key: 801b0a72-4e74-4c1e-916e-441a6a09215d
Public Version Date: November 01, 2023
Public Version Number: 2
DI Record Publish Date: May 25, 2018