OneCath 1616

GUDID 00852141007185

The OneCath Intermittent Urinary Catheter is a sterile, single-use urine drainage catheter for use in draining urine from the bladder in subjects with urine drainage problems.

COMPACTCATH, INC.

Single-administration urethral catheterization kit, single-use

• Primary Device ID: 00852141007185
• NIH Device Record Key: 95c5eea2-75c2-445c-8383-f3ac092c3c3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneCath
• Version Model Number: 201-1616
• Catalog Number: 1616
• Company DUNS: 054765780
• Company Name: COMPACTCATH, INC.
• Device Count: 25
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 (888) 933-2284
• Email: support@compactcath.com

Device Dimensions

• Catheter Gauge: 16 French
• Catheter Gauge: 16 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852141007185 [Primary]
GS1	00852141007635 [Unit of Use]

FDA Product Code

• EZD: Catheter, Straight

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-01-18
• Device Publish Date: 2018-06-25

On-Brand Devices [OneCath]

• 00852141007338: The OneCath Intermittent Urinary Catheter is a sterile, single-use urine drainage catheter for u
• 00852141007246: The OneCath Intermittent Urinary Catheter is a sterile, single-use urine drainage catheter for u
• 00852141007215: The OneCath Intermittent Urinary Catheter is a sterile, single-use urine drainage catheter for u
• 00852141007208: The OneCath Intermittent Urinary Catheter is a sterile, single-use urine drainage catheter for u
• 00852141007192: The OneCath Intermittent Urinary Catheter is a sterile, single-use urine drainage catheter for u
• 00852141007185: The OneCath Intermittent Urinary Catheter is a sterile, single-use urine drainage catheter for u
• 00852141007178: The OneCath Intermittent Urinary Catheter is a sterile, single-use urine drainage catheter for u
• 00852141007154: The OneCath Intermittent Urinary Catheter is a sterile, single-use urine drainage catheter for u
• 00852141007109: The OneCath Intermittent Urinary Catheter is a sterile, single-use urine drainage catheter for u
• 00852141007079: The OneCath Intermittent Urinary Catheter is a sterile, single-use urine drainage catheter for u