Silicone Gastrostomy Tube with ENFit Connector (Bi-Funnel) 70-0056-114

GUDID 00813939024852

Silicone Gastrostomy Tube with ENFit Connector (Bi-Funnel) 14FR

XERIDIEM MEDICAL DEVICES, INC.

Gastrostomy tube Gastrostomy tube

• Primary Device ID: 00813939024852
• NIH Device Record Key: 50fc7fc4-f120-4f92-925f-5235cb8005b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Gastrostomy Tube with ENFit Connector (Bi-Funnel)
• Version Model Number: 70-0056-114
• Catalog Number: 70-0056-114
• Company DUNS: 183325125
• Company Name: XERIDIEM MEDICAL DEVICES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: (520) 882-7794
• Email: smurray@xeridiem.com
• Phone: (520) 882-7794
• Email: smurray@xeridiem.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813939024715 [Primary]
GS1	00813939024852 [Package]; Contains: 00813939024715; Package: Case Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142075

FDA Product Code

• PIF: Gastrointestinal Tubes With Enteral Specific Connectors

Sterilization

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

Device Entry Metadata

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

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