BD BBL™ MGIT™ OADC Enrichment

Basic Information

• Brand Name: BD BBL™ MGIT™ OADC Enrichment
• Primary DI: 30382902451168
• Version / Model: 245116
• Catalog Number: 245116
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2018-05-25
• Public Version: 3
• Public Version Date: 2023-10-09
• Public Version Status: Update
• Public Device Record Key: 18153f3e-8463-451d-b46d-595225f1cb64

Device Description

BD BBL™ MGIT™ OADC Enrichment

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
MDB	SYSTEM, BLOOD CULTURING	Microbiology	866.2560	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62160	Culture medium nutrient supplement IVD	A formulation of non-selective supplements containing nutrients e.g., (amino acids, sugars, minerals) or other additives (e.g., serum, haemoglobin) intend to enrich a culture medium to sustain and/or enhance the growth or isolation of a specific target microbial species from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30382902451168	GS1
Unit of Use	00382902451167	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K954932	000
K974883	000

Device Sizes

Type	Value	Unit	Text
Total Volume	15	Milliliter

Storage Conditions

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