CVX-RIPE CVX-100

GUDID H671CVX1001

Double-balloon cervical dilatation catheter for cervical ripening

UTAH MEDICAL PRODUCTS, INC.

Cervical dilatation catheter

• Primary Device ID: H671CVX1001
• NIH Device Record Key: c3d8b4bf-dbc7-4046-a239-3ec2424551d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CVX-RIPE
• Version Model Number: CVX-100
• Catalog Number: CVX-100
• Company DUNS: 094651270
• Company Name: UTAH MEDICAL PRODUCTS, INC.
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 801-566-1200
• Email: customer@utahmed.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H671CVX1000 [Primary]
HIBCC	H671CVX1001 [Package]; Contains: H671CVX1000; Package: box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143424

FDA Product Code

• PFJ: Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor

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: 2018-12-17
• Device Publish Date: 2018-11-16

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