QwikCheck Beads

GUDID 07290012140136

M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.

Sperm energy status and motility testing reagent IVD Sperm energy status and motility testing reagent IVD Sperm energy status and motility testing reagent IVD Sperm energy status and motility testing reagent IVD Sperm energy status and motility testing reagent IVD Sperm energy status and motility testing reagent IVD Sperm energy status and motility testing reagent IVD Sperm energy status and motility testing reagent IVD Sperm energy status and motility testing reagent IVD Sperm energy status and motility testing reagent IVD Sperm energy status and motility testing reagent IVD Sperm energy status and motility testing reagent IVD Sperm energy status and motility testing reagent IVD Sperm energy status and motility testing reagent IVD Sperm energy status and motility testing reagent IVD Sperm energy status and motility testing reagent IVD Sperm energy status and motility testing reagent IVD

• Primary Device ID: 07290012140136
• NIH Device Record Key: 47a7c1e6-c703-4155-a7c1-2285bf7a9085
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QwikCheck Beads
• Version Model Number: QwikCheck Beads 3 Levels
• Company DUNS: 514680529
• Company Name: M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290012140136 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041600

FDA Product Code

• NRF: Material, Quality Control, Semen Analysis

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-16
• Device Publish Date: 2023-06-08

Devices Manufactured by M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.

• 07290016650402 - SQA-iO Sperm Quality Analyzer: 2023-09-14
• 07290012140136 - QwikCheck Beads: 2023-06-16
• 07290012140136 - QwikCheck Beads: 2023-06-16
• 07290012140143 - QwikCheck Dilution Kit: 2023-06-16
• 07290012140150 - QwikCheck Liquefaction: 2023-06-16
• 07290012140600 - QwikCheck Beads Proficiency and Training Kit: 2023-06-16
• 07290012140891 - QwikCheck Vitality Kit: 2023-06-16
• 07290016650020 - QwikCheck Beads Precision and Linearity kit: 2023-06-16
• 07290016650617 - QwikCheck DFI Kit: 2023-06-16