AccessGUDID - DEVICE: BD BBL™ Sensi-Disc™ Single Disc Dispenser (30382902604595)

GUDID

Device Identifier (DI) Information

Brand Name: BD BBL™ Sensi-Disc™ Single Disc Dispenser
Version or Model: 260459
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 260459
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382902604595
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 6
Labeler D-U-N-S® Number*: 122561087 *Terms of Use

Device Description: BD BBL™ Sensi-Disc™ Single Disc Dispenser

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
LXG	EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE

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
Special Storage Condition, Specify: Room Temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 93d68c77-e251-42df-88b9-e7c349098102
Public Version Date: May 08, 2025
Public Version Number: 5
DI Record Publish Date: May 19, 2016