OneCath Lubricated 2041-1614

GUDID 00852141007871

The OneCath Lubricated 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: 00852141007871
• NIH Device Record Key: 92c5d601-bb9b-43dc-be43-c325ebb23861
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneCath Lubricated
• Version Model Number: 2041-1614
• Catalog Number: 2041-1614
• Company DUNS: 054765780
• Company Name: COMPACTCATH, INC.
• Device Count: 30
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Length: 16 Inch
• Catheter Gauge: 14 French
• Length: 16 Inch
• Catheter Gauge: 14 French
• Length: 16 Inch
• Catheter Gauge: 14 French
• Length: 16 Inch
• Catheter Gauge: 14 French
• Length: 16 Inch
• Catheter Gauge: 14 French
• Length: 16 Inch
• Catheter Gauge: 14 French
• Length: 16 Inch
• Catheter Gauge: 14 French
• Length: 16 Inch
• Catheter Gauge: 14 French
• Length: 16 Inch
• Catheter Gauge: 14 French
• Length: 16 Inch
• Catheter Gauge: 14 French
• Length: 16 Inch
• Catheter Gauge: 14 French
• Length: 16 Inch
• Catheter Gauge: 14 French
• Length: 16 Inch
• Catheter Gauge: 14 French
• Length: 16 Inch
• Catheter Gauge: 14 French
• Length: 16 Inch
• Catheter Gauge: 14 French
• Length: 16 Inch
• Catheter Gauge: 14 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852141007871 [Unit of Use]
GS1	00852141007925 [Primary]

FDA Product Code

• EZD: Catheter, Straight

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: 2021-10-04
• Device Publish Date: 2021-09-25

On-Brand Devices [OneCath Lubricated]

• 00852141007895: The OneCath Lubricated Intermittent Urinary Catheter is a sterile, single-use urine drainage cat
• 00852141007871: The OneCath Lubricated Intermittent Urinary Catheter is a sterile, single-use urine drainage cat