EndoVive Gastrostomy Tube, Straight, with ENFit Connector 70-0051-218

GUDID 00813939023619

EndoVive Gastrostomy Tube, Straight, with ENFit Connector, 18FR

XERIDIEM MEDICAL DEVICES, INC.

Gastrostomy tube

• Primary Device ID: 00813939023619
• NIH Device Record Key: 6f91d09e-8f76-4551-a149-7a92a24d7a27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoVive Gastrostomy Tube, Straight, with ENFit Connector
• Version Model Number: M00509910
• Catalog Number: 70-0051-218
• 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	00813939023619 [Primary]
GS1	00813939023893 [Package]; 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: 2016-08-02

On-Brand Devices [EndoVive Gastrostomy Tube, Straight, with ENFit Connector]

• 00813939023923: EndoVive Gastrostomy Tube, Straight, with ENFit Connector, 24FR
• 00813939023916: EndoVive Gastrostomy Tube, Straight, with ENFit Connector, 22FR
• 00813939023909: EndoVive Gastrostomy Tube, Straight, with ENFit Connector, 20FR
• 00813939023619: EndoVive Gastrostomy Tube, Straight, with ENFit Connector, 18FR
• 00813939023886: EndoVive Gastrostomy Tube, Straight, with ENFit Connector, 16FR
• 00813939023879: EndoVive Gastrostomy Tube, Straight, with ENFit Connector, 14 FR
• 00813939023862: EndoVive Gastrostomy Tube, Straight, with ENFit Connector, 12 FR