BT-CATH BTC-ESY

GUDID H671BTCESY1

Balloon Tamponade Catheter for Postpartum Uterine Hemorrhage with EasyFill Inflation System

UTAH MEDICAL PRODUCTS, INC.

Intrauterine haemostatic balloon catheter

• Primary Device ID: H671BTCESY1
• NIH Device Record Key: c2e92c6b-ab57-412c-bdff-6a6ca9f2880c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BT-CATH
• Version Model Number: EasyFill
• Catalog Number: BTC-ESY
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-533-4984
• Email: customer@utahmed.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H671BTCESY0 [Primary]
HIBCC	H671BTCESY1 [Package]; Contains: H671BTCESY0; Package: Box [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101535

FDA Product Code

• OQY: Intrauterine Tamponade Balloon

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: 2019-12-18
• Device Publish Date: 2016-09-23

On-Brand Devices [BT-CATH]

• H671BTCESY1: Balloon Tamponade Catheter for Postpartum Uterine Hemorrhage with EasyFill Inflation System
• H671BTC1001: Balloon Tamponade Catheter for Postpartum Uterine Hemorrhage