BD BBL™ Sensi-Disc™ Ciprofloxacin - 5 µg

Basic Information

• Brand Name: BD BBL™ Sensi-Disc™ Ciprofloxacin - 5 µg
• Primary DI: 30382902316580
• Version / Model: 231658
• Catalog Number: 231658
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-05-03
• Public Version: 4
• Public Version Date: 2023-09-13
• Public Version Status: Update
• Public Device Record Key: e75f202a-ef12-4c70-a0ea-2b3ad2a73f17

Device Description

BD BBL™ Sensi-Disc™ Ciprofloxacin 5 µg

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JTN	SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL	Microbiology	866.1620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63834	Antibacterial susceptibility testing disc IVD	A susceptibility testing disc impregnated with a defined amount of a specific an antibacterial, also known as an antibiotic (i.e., a drug intended for treatment and/or prevention of a bacterial infection) intended to be used to determine the susceptibility of a specific bacterial organism (excluding mycobacteria) isolated from a clinical specimen by culture, using a disc diffusion method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30382902316580	GS1
Unit of Use	00382902316589	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K874425	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 8 Degrees Celsius