BD BACTEC™ MGIT™ Mycobacteria Growth Indicator Tubes

Basic Information

• Brand Name: BD BACTEC™ MGIT™ Mycobacteria Growth Indicator Tubes
• Primary DI: 00382902451228
• Version / Model: 245122
• Catalog Number: 245122
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-07
• Public Version: 1
• Public Version Date: 2026-01-15
• Public Version Status: New
• Public Device Record Key: 37663d97-d5b4-4d39-9bed-03577c6234b6

Device Description

BD BBL™ MGIT™ Mycobacteria Growth Indicator Tubes, 7 mL, carton of 100 tubes

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
58684	Differential/selective broth culture medium IVD	A broth 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 in the same medium. 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
Primary	00382902451228	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K974883	000

Device Sizes

Type	Value	Unit	Text
Total Volume	7	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Fragile, handle with care
• Type: Special Storage Condition, Specify
• Special Conditions: This way up
• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from light