Kitazato IUI Catheter with Stainless Steel Center Core Type Type1-v1 100101

GUDID 14580303269043

KITAZATO CORPORATION

Assisted reproduction transfer catheter/set

• Primary Device ID: 14580303269043
• NIH Device Record Key: d2e24060-03a3-42a2-8f92-c00cc994352e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kitazato IUI Catheter with Stainless Steel Center Core Type Type1-v1
• Version Model Number: 100101 Type1-v1
• Catalog Number: 100101
• 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	04580303269046 [Primary]
GS1	14580303269043 [Package]; Contains: 04580303269046; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112396

FDA Product Code

• MQF: CATHETER, ASSISTED REPRODUCTION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-23
• Device Publish Date: 2016-11-09

Devices Manufactured by KITAZATO CORPORATION

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• 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