EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector 70-0053-116

GUDID 00813939024029

EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector, 16FR

XERIDIEM MEDICAL DEVICES, INC.

Gastrostomy tube

• Primary Device ID: 00813939024029
• NIH Device Record Key: 854b8f5a-ee82-4650-9480-61fc5e0c62b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector
• Version Model Number: M00509980
• Catalog Number: 70-0053-116
• 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	00813939023749 [Primary]
GS1	00813939024029 [Package]; Contains: 00813939023749; 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: 2016-08-03

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

• 00813939024067: EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector, 24FR
• 00813939024050: EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector, 22FR
• 00813939024043: EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector, 20FR
• 00813939024036: EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector, 18FR
• 00813939024029: EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector, 16FR
• 00813939024012: EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector, 14FR
• 00813939024005: EndoVive Gastrostomy Tube, Right Angle, with ENFit Connector, 12FR