BD Molecular Urine Transport Kit

Basic Information

• Brand Name: BD Molecular Urine Transport Kit
• Primary DI: 00382904439248
• Version / Model: 443924
• Catalog Number: 443924
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-16
• Public Version: 2
• Public Version Date: 2024-06-05
• Public Version Status: Update
• Public Device Record Key: e9954d3d-a34b-4414-966a-88e319caadca

Device Description

Molecular Urine Transport Kit 96EA

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
LSL	DNA-REAGENTS, NEISSERIA	Microbiology	866.3390	2
MKZ	DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA	Microbiology	866.3120	1
OUY	Trichomonas vaginalis nucleic acid amplification test system	Immunology	866.3860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58177	Urine specimen collection kit IVD	A collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00382904439248	GS1
Package	30382904439249	GS1	Shelfpack	96	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K182692	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 33 Degrees Celsius