URI-CATH 4193509

GUDID H67141935091

Urinary Drainage and Collection Set with a Silicone Urinary Drainage Catheter, 3.5 French, w/o Iodine

UTAH MEDICAL PRODUCTS, INC.

Single-administration urethral drainage catheter

• Primary Device ID: H67141935091
• NIH Device Record Key: b8e44ca8-0813-4a85-bb28-332caeb45e59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: URI-CATH
• Version Model Number: Silicone Catheter Set
• Catalog Number: 4193509
• 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: true
• 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: 3.5 French

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H67141935090 [Primary]
HIBCC	H67141935091 [Package]; Contains: H67141935090; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941672

FDA Product Code

• GBM: Catheter, Urethral

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 [URI-CATH]

• H67141980091: Urinary Drainage and Collection Set with a Silicone Urinary Drainage Catheter, 8 French, w/o Iod
• H67141980071: Urinary Drainage and Collection Set with a Silicone Urinary Drainage Catheter, 8 French
• H67141980051: A Silicone Urinary Drainage Catheter, 8 French
• H67141950091: Urinary Drainage and Collection Set with a Silicone Urinary Drainage Catheter, 5 French, w/o Iod
• H67141950071: Urinary Drainage and Collection Set with a Silicone Urinary Drainage Catheter, 5 French
• H67141950051: A Silicone Urinary Drainage Catheter, 5 French
• H67141935091: Urinary Drainage and Collection Set with a Silicone Urinary Drainage Catheter, 3.5 French, w/o I
• H67141935071: Urinary Drainage and Collection Set with a Silicone Urinary Drainage Catheter, 3.5 French
• H67141935051: A Silicone Urinary Drainage Catheter, 3.5 French
• H67141900011: PEDIATRIC URINE METER for Urinary Drainage Collection
• H67141965071: Urinary Drainage and Collection Set with a Silicone Urinary Drainage Catheter, 6.5 French
• H67141965051: A Silicone Urinary Drainage Catheter, 6.5 French