kitazato IUI Catheter 131184

GUDID 14580303269197

Catheter with Outer Stiffener without Stylet Cannula, 18cm, model number Type4-v1

KITAZATO CORPORATION

Assisted reproduction transfer catheter/set

• Primary Device ID: 14580303269197
• NIH Device Record Key: e8ca1931-9121-43b1-81cf-a9de8920aa2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: kitazato IUI Catheter
• Version Model Number: 131184 Type4-v1
• Catalog Number: 131184
• 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	04580303269190 [Primary]
GS1	14580303269197 [Package]; Contains: 04580303269190; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162667

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: 2020-01-09
• Device Publish Date: 2018-01-25

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