nfant® Coupling NC2-1

GUDID 00861410000239

NFANT LABS LLC

Biofeedback system

• Primary Device ID: 00861410000239
• NIH Device Record Key: 56342529-a7a8-4c77-9cf7-cb79c442508b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: nfant® Coupling
• Version Model Number: 1
• Catalog Number: NC2-1
• Company DUNS: 080007197
• Company Name: NFANT LABS LLC
• 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: 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: 1-800-761-7601
• Email: info@nfant.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861410000222 [Package]; Package: [25 Units]; In Commercial Distribution
GS1	00861410000239 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143507

FDA Product Code

• HCC: Device, Biofeedback

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

Devices Manufactured by NFANT LABS LLC

• 00196852268917 - nfant® Thrive Feeding System: 2023-03-29
• 00861410000208 - nfant® Patient Database: 2018-07-06
• 00861410000215 - nfant® SSB Sensor: 2018-07-06
• 00861410000239 - nfant® Coupling: 2018-07-06
• 00861410000239 - nfant® Coupling: 2018-07-06
• 00861410000246 - nfant® Mobile App: 2018-07-06