COMPACTCATH N1612

GUDID 00852141007000

The CompactCath Intermitten 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: 00852141007000
• NIH Device Record Key: 1c4fe563-b78d-411b-8447-657c8186ab57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMPACTCATH
• Version Model Number: 40788
• Catalog Number: N1612
• Company DUNS: 054765780
• Company Name: COMPACTCATH, 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: 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: 650-614-1680
• Email: support@compactcath.com

Device Dimensions

• Catheter Gauge: 12 French
• Catheter Gauge: 12 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852141007000 [Primary]
GS1	00852141007017 [Package]; Package: CASE [30 Units]; In Commercial Distribution

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: 2018-03-29
• Device Publish Date: 2017-04-20

On-Brand Devices [COMPACTCATH]

• 00852141007123: The CompactCath Intermittent Urinary Catheter is a sterile, single-use urine drainage catheter f
• 10852141007069: The CompactCath Intermittent Urinary Catheter is a sterile, single-use urine drainage catheter f
• 00852141007024: The CompactCath Intermitten Urinary Catheter is a sterile, single use urine drainage catheter fo
• 00852141007000: The CompactCath Intermitten Urinary Catheter is a sterile, single use urine drainage catheter fo