BD MAX™ UVE Sample Buffer Tubes

Basic Information

• Brand Name: BD MAX™ UVE Sample Buffer Tubes
• Primary DI: 30382904434206
• Version / Model: 443420
• Catalog Number: 443420
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 48
• Record Status: Published
• Publish Date: 2016-10-17
• Public Version: 5
• Public Version Date: 2022-08-03
• Public Version Status: Update
• Public Device Record Key: c592a1f8-9bba-4045-b43d-7f257b20a6f0

Device Description

BD MAX ™ UVE Sample Buffer Tubes Contains: 48 x 1.5 mL Sample Buffer 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
OUY	Trichomonas vaginalis nucleic acid amplification test system	Immunology	866.3860	2
LSL	DNA-REAGENTS, NEISSERIA	Microbiology	866.3390	2
MKZ	DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA	Microbiology	866.3120	1

GMDN Terms

Code	Name	Definition	Implantable	Status
50409	Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with sexually transmitted infections (STI), in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include (but are not limited to) Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma species, Ureaplasma species, Treponema pallidum, Trichomonas vaginalis, herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30382904434206	GS1
Unit of Use	00382904434205	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K151589	000

Device Sizes

Type	Value	Unit	Text
Total Volume	1.5	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius