OneCath Hydro 2031-0812

GUDID 00810053920046

The OneCath-Hydro Hydrophilic 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: 00810053920046
• NIH Device Record Key: 81b03407-ac07-4891-acbb-95f1e1b64c13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneCath Hydro
• Version Model Number: 2031-0812
• Catalog Number: 2031-0812
• 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: true
• 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
• 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: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French
• Length: 8 Inch
• Catheter Gauge: 12 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810053920046 [Unit of Use]
GS1	10810053920043 [Primary]

FDA Product Code

• GBM: Catheter, Urethral

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: 2021-11-01
• Device Publish Date: 2021-10-23

On-Brand Devices [OneCath Hydro]

• 00810053920084: The OneCath-Hydro Hydrophilic Intermittent Urinary Catheter is a sterile, single-use urine drain
• 00810053920046: The OneCath-Hydro Hydrophilic Intermittent Urinary Catheter is a sterile, single-use urine drain
• 00810053920039: The OneCath-Hydro Hydrophilic Intermittent Urinary Catheter is a sterile, single-use urine drain