Bolink(TM) 1405

GUDID 00867622000418

Large Cap Gravity Feeding Set with ENFit Connector

U DELIVER MEDICAL L.L.C.

Enteral feeding kit, adult/paediatric, non-sterile

• Primary Device ID: 00867622000418
• NIH Device Record Key: 7fa0391e-bbd2-434f-9037-373290539f5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bolink(TM)
• Version Model Number: 1405
• Catalog Number: 1405
• Company DUNS: 080494259
• Company Name: U DELIVER MEDICAL L.L.C.
• 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9522000270
• Email: info@udelivermed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867622000418 [Primary]
GS1	10867622000415 [Package]; Package: Carton [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170555

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-19

On-Brand Devices [Bolink(TM) ]

• 00867622000418: Large Cap Gravity Feeding Set with ENFit Connector
• 00867622000401: Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector