AccessGUDID - DEVICE: BD BBL™ Nitrate Broth with Durham Tube (30382902218303)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ Nitrate Broth with Durham Tube
Version or Model: 221830
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 221830
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382902218303
Issuing Agency: GS1
Commercial Distribution End Date: June 09, 2022
Device Count: 10
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD BBL™ Nitrate Broth with Durham Tube

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?
35841	Nitrate reduction microbial reagent IVD	One or multiple substances or reactants intended to be used in microbial testing to detect nitratase enzyme production, by demonstrating the reduction of nitrate through a visible colour change in an organism isolated from a clinical specimen by culture.	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 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 14c89163-0499-4844-8f6d-9c4d903bf3bd
Public Version Date: October 17, 2024
Public Version Number: 3
DI Record Publish Date: May 25, 2018