AccessGUDID - DEVICE: BD BBL™ Brucella Agar with 5% SB, Hemin and Vitamin K1 (10382902978487)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ Brucella Agar with 5% SB, Hemin and Vitamin K1
Version or Model: 297848
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 297848
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 10382902978487
Issuing Agency: GS1
Commercial Distribution End Date: April 15, 2022
Device Count: 10
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: Plate Brucella 5% SB Hemin Vit K1 20 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?
58688	Enriched agar culture medium IVD	An agar 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 on general-purpose agar medium.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KZI	CULTURE MEDIA, ENRICHED

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
Depth: 15 Millimeter
Outer Diameter: 100 Millimeter

Device Record Status

Public Device Record Key: 8391d57b-e360-443f-90a0-d0f3e4d92b0f
Public Version Date: November 01, 2023
Public Version Number: 2
DI Record Publish Date: May 25, 2018