AccessGUDID - DEVICE: Visby Medical Sexual Health Click Test (00810031720002)

GUDID

Device Identifier (DI) Information

Brand Name: Visby Medical Sexual Health Click Test
Version or Model: 000175
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PS-000688
Company Name: Visby Medical, Inc.

Primary DI Number: 00810031720002
Issuing Agency: GS1
Commercial Distribution End Date: June 17, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 933894748 *Terms of Use

Device Description: Visby Medical Sexual Health Click Test

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LSL	Dna-Reagents, Neisseria
MKZ	Dna Probe, Nucleic Acid Amplification, Chlamydia
OUY	Trichomonas Vaginalis Nucleic Acid Amplification Test System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200748	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a3d86d9f-edfc-4190-9f2e-a09dc338c466
Public Version Date: June 28, 2023
Public Version Number: 2
DI Record Publish Date: September 15, 2021