Cephus Catheter

GUDID 10860000559123

Sealcath, LLC

Enema tip, single-use

• Primary Device ID: 10860000559123
• NIH Device Record Key: 5dc9acbc-cccf-4a7d-bbf1-c9e714ba93ba
• 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: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French
• Catheter Gauge: 20 French

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860000559126 [Primary]
GS1	10860000559123 [Package]; Contains: 00860000559126; 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