ENFit Feeding Port Transition Connector 30-0425

GUDID 10813939024972

ENFit Feeding Port Transition Connector

XERIDIEM MEDICAL DEVICES, INC.

Gastrostomy tube

• Primary Device ID: 10813939024972
• NIH Device Record Key: 2797055a-4fb0-474f-aa71-00f4ed69a9f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENFit Feeding Port Transition Connector
• Version Model Number: M00509240
• Catalog Number: 30-0425
• Company DUNS: 183325125
• Company Name: XERIDIEM MEDICAL DEVICES, 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: false
• 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: 520-882-7794
• Email: smurray@xeridiem.com
• Phone: 520-882-7794
• Email: smurray@xeridiem.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813939024975 [Primary]
GS1	10813939024972 [Package]; Contains: 00813939024975; Package: Case Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142297

FDA Product Code

• PIF: Gastrointestinal Tubes With Enteral Specific Connectors

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-08-01

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