Kitazato ET Catheter Type5-v2 EC-PRO Stylet 294020

GUDID 14580303269791

4.7Fr EC-PRO Soft Stylet for 190mm Outer Guide

KITAZATO CORPORATION

Assisted reproduction transfer catheter/set

• Primary Device ID: 14580303269791
• NIH Device Record Key: ea8818ea-dc06-4870-82d5-9a7d8bf813cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kitazato ET Catheter Type5-v2 EC-PRO Stylet
• Version Model Number: 294020 Type5-2 EC-PRO Stylet
• Catalog Number: 294020
• Company DUNS: 711091157
• Company Name: KITAZATO CORPORATION
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• 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	04580303269794 [Primary]
GS1	14580303269791 [Package]; Contains: 04580303269794; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162878

FDA Product Code

• MQF: CATHETER, ASSISTED REPRODUCTION

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-07

Devices Manufactured by KITAZATO CORPORATION

• 14573316386173 - ES(Equilibration Solution) Pack 4 vials: 2024-12-03 ES(Equilibration Solution) Pack 4x1.5ml vials
• 14573316385480 - BS(Basic Solution) Pack 4 vials: 2024-10-25 BS(Basic Solution) Pack of 4x1.5ml vials
• 14573316385497 - ES(Equilibration Solution) Pack 4 vials: 2024-10-25 ES(Equilibration Solution) Pack 4x1.5ml vials
• 14573316385503 - VS(Vitrification Solution) Pack 4 vials: 2024-10-25 VS(Vitrification Solution) Pack of 4x1.5ml vials
• 14573316385510 - BS(Basic Solution) Pack 4 vials 4ml: 2024-10-25 BS(Basic Solution) Pack of 4x4ml vials
• 14573316385527 - ES(Equilibration Solution) Pack 4 vials 4ml: 2024-10-25 ES(Equilibration Solution) Pack 4x4ml vials
• 14573316385534 - VS(Vitrification Solution) Pack 4 vials 4ml: 2024-10-25 VS(Vitrification Solution) Pack of 4x4ml vials
• 14573316385558 - DS(Diluent Solution) Pack 4 vials: 2024-10-25 DS(Diluent Solution) Pack of 4x4ml vials