AccessGUDID - DEVICE: BD BBL™ Prompt™ Inoculation System (30382902263068)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ Prompt™ Inoculation System
Version or Model: 226306
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 226306
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382902263068
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 60
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD BBL™ Prompt™ Inoculation System

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:	No
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?
35733	Antimicrobial sensitivity disc dispenser IVD	A manually-operated IVD intended to be used for the storage and/or dispensing of antimicrobial sensitivity discs impregnated with antimicrobial agents onto agar or other culture media, for the antimicrobial susceptibility testing of culture isolates from clinical laboratory specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LIE	REAGENT/DEVICE, INOCULUM CALIBRATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K820299	000

Device Exempt from Premarket Submission: No 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 27 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f46e80a8-2e19-4eed-887f-904482861491
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 29, 2016