THORA-CATH 4141209

GUDID H67141412091

DRAINAGE CATHETER - 12 FRENCH, A Silicone Chest Drainage Catheter with Trocar

UTAH MEDICAL PRODUCTS, INC.

Mediastinal drainage catheter

• Primary Device ID: H67141412091
• NIH Device Record Key: a7bc6b1d-0cc4-4ea2-a28d-7cc1d5219a5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THORA-CATH
• Version Model Number: 12 French
• Catalog Number: 4141209
• 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: 800-533-4984
• Email: customer@utahmed.com

Device Dimensions

• Catheter Gauge: 12 French

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H67141412090 [Primary]
HIBCC	H67141412091 [Package]; Contains: H67141412090; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941232

FDA Product Code

• JOL: Catheter And Tip, Suction

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 [THORA-CATH]

• H67141496091: DRAINAGE CATHETER - 9.6 FRENCH, A Silicone Chest Drainage Catheter with Trocar
• H67141414091: DRAINAGE CATHETER - 14 FRENCH, A Silicone Chest Drainage Catheter with Trocar
• H67141412091: DRAINAGE CATHETER - 12 FRENCH, A Silicone Chest Drainage Catheter with Trocar