Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection 70-0060-116

GUDID 10827002447827

Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 16 FR

XERIDIEM MEDICAL DEVICES, INC.

Gastrostomy tube

• Primary Device ID: 10827002447827
• NIH Device Record Key: e693f54b-3a2e-4785-b6d7-e8960276a8f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection
• Version Model Number: SBRD-16-ENF
• Catalog Number: 70-0060-116
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00827002447820 [Primary]
GS1	10827002447827 [Package]; Contains: 00827002447820; Package: Case Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130611

FDA Product Code

• KNT: Tubes, Gastrointestinal (And Accessories)

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: 2016-08-01

On-Brand Devices [Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection]

• 10827002447858: Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 22 FR
• 10827002447841: Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 20 FR
• 10827002447865: Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 24 FR
• 10827002447834: Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 18 FR
• 10827002447827: Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 16 FR
• 10827002447810: Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 14 FR
• 10827002447803: Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 12 FR