BD BBL™ GC-Lect™ Agar

Basic Information

• Brand Name: BD BBL™ GC-Lect™ Agar
• Primary DI: 10382902977152
• Version / Model: 297715
• Catalog Number: 297715
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-12-21
• Public Version: 4
• Public Version Date: 2023-10-25
• Public Version Status: Update
• Public Device Record Key: 31d25415-03f3-46b6-94ff-2bdb3d212379
• Distribution End Date: 2022-04-07

Device Description

BD BBL™ GC-Lect™ Agar

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
JTY	CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA	Microbiology	866.2410	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58585	Differential/selective agar culture medium IVD	An agar culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing on the same medium by appearance (e.g., colour, shape, growth pattern). It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30382902977156	GS1	Shelfpack	2	Not in Commercial Distribution	2022-04-07
Primary	10382902977152	GS1
Unit of Use	00382902977155	GS1
Package	60382902977157	GS1	US pallet	400	Not in Commercial Distribution	2022-04-07

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K864803	000

Device Sizes

Type	Value	Unit	Text
Depth	15	Millimeter
Outer Diameter	100	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius