Cephus Catheter

GUDID 10860000559116

Sealcath, LLC

Barium enema catheter

• Primary Device ID: 10860000559116
• NIH Device Record Key: 98e7d208-1d02-477a-8f43-8bc80ab15f9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cephus Catheter
• Version Model Number: 0006560
• Company DUNS: 079172500
• Company Name: Sealcath, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)917-1453
• Email: support@sealcath.com

Device Dimensions

• Catheter Gauge: 30 French

Operating and Storage Conditions

• Storage Environment Temperature: Between 60 Degrees Fahrenheit and 76 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000559119 [Primary]
GS1	10860000559116 [Package]; Contains: 00860000559119; Package: Box [10 Units]; In Commercial Distribution

FDA Product Code

• FCE: Enema kit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-07-22
• Device Publish Date: 2018-11-30

On-Brand Devices [Cephus Catheter]

• 10860000559147: 0006560
• 10860000559130: 0006560
• 10860000559123: 0006560
• 10860000559116: 0006560
• 10860000559109: 0006560