Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack

Basic Information

• Brand Name: Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack
• Primary DI: 00810031720057
• Version / Model: PS-000715
• Catalog Number: PS-000715
• Company Name: Visby Medical, Inc.
• Labeler DUNS: 933894748
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2021-09-15
• Public Version: 1
• Public Version Date: 2021-09-23
• Public Version Status: New
• Public Device Record Key: c455a516-eb6c-4a13-9ae1-a6445cdd3c03

Device Description

Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack.

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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
61144	Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical	A collection of devices intended exclusively for professional use to collect a clinical specimen at the point-of-care for subsequent in vitro diagnostic investigation of sexually transmitted infections (STI) [e.g., Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, syphilis and human immunodeficiency virus (HIV)]. It consists of one or multiple transport containers, with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)], and sampling/collection tool(s) [e.g., vaginal, rectal or oropharyngeal swab, brush, spatula, lancet, pipette]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810031720057	GS1
Unit of Use	00810031720002	GS1

Premarket Submissions

Submission Number	Supplement Number
K200748	000