Kitazato IUI Catheter 131194

GUDID 14580745041252

KITAZATO CORPORATION

Assisted reproduction transfer catheter/set

• Primary Device ID: 14580745041252
• NIH Device Record Key: 48c4c012-30b6-4367-8ee6-e1ffbfb55cce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kitazato IUI Catheter
• Version Model Number: 131194
• Catalog Number: 131194
• 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	04580745041255 [Primary]
GS1	14580745041252 [Package]; Contains: 04580745041255; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131491

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: 2022-10-05
• Device Publish Date: 2022-09-27

On-Brand Devices [Kitazato IUI Catheter]

• 14580303269289: Stylet for 100mm Catheter, model number Type6-v2
• 14580303269272: Stylet for 180mm Catheter, model number Type6-v1
• 14580303269265: Catheter with Outer Stiffener with Stainless Steel Core, 10cm, model number Type5-v4
• 14580303269258: Catheter with Outer Stiffener with Stainless Steel Core, 10cm, model number Type5-v3
• 14580303269241: Catheter with Outer Stiffener with Stainless Steel Core, 18cm, model number Type5-v2
• 14580303269234: Catheter with Outer Stiffener with Stainless Steel Core, 18cm, model number Type5-v1
• 14580303269227: Catheter with Outer Stiffener without Stylet Cannula, 10cm, model number Type4-v4
• 14580303269210: Catheter with Outer Stiffener without Stylet Cannula, 10cm, model number Type4-v3
• 14580303269203: Catheter with Outer Stiffener without Stylet Cannula, 18cm, model number Type4-v2
• 14580303269197: Catheter with Outer Stiffener without Stylet Cannula, 18cm, model number Type4-v1
• 14580745041283: 140208
• 14580745041276: 140128
• 04580745041262: 131196
• 14580745041252: 131194
• 04580745041248: 131192
• 04580745041231: 131191
• 14580745041221: 131116
• 04580745041217: 131114
• 14580745041207: 131112
• 14580745041191: 131111