Septal-H™ CP-5400

GUDID 10889483225431

Septal-H™ Premie Size

SUNMED, LLC

Personal device holder, single-use

• Primary Device ID: 10889483225431
• NIH Device Record Key: 93eb947b-93dd-4c00-8855-dd182da8aa33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Septal-H™
• Version Model Number: CP-5400
• Catalog Number: CP-5400
• Company DUNS: 069009268
• Company Name: SUNMED, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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: 1-800-433-2797
• Email: info@sun-med.com
• Phone: 1-800-433-2797
• Email: info@sun-med.com
• Phone: 1-800-433-2797
• Email: info@sun-med.com
• Phone: 1-800-433-2797
• Email: info@sun-med.com
• Phone: 1-800-433-2797
• Email: info@sun-med.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709078013119 [Previous]
GS1	10889483225431 [Primary]
GS1	20889483225438 [Package]; Package: Box [80 Units]; In Commercial Distribution

FDA Product Code

• JAY: Support, Breathing Tube

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-23
• Device Publish Date: 2025-12-15

On-Brand Devices [Septal-H™]

• 10889483225455: Septal-H™ Infant Size
• 10889483225448: Septal-H™ Neonatal Size
• 10889483225431: Septal-H™ Premie Size