bFed™ SK-2001

GUDID 00867622000449

bFed Starter kit containing 5 Large Cap Bolink™ Gravity Feeding Sets with ENFit® Connector (00867622000418), 2 Small Cap Bolink™ Gravity Feeding Sets with Cross Spike (00867622000401) and ENFit® Connectors and 3 375 mL Bolee™ Bags

U DELIVER MEDICAL L.L.C.

Enteral feeding kit, adult/paediatric, non-sterile

• Primary Device ID: 00867622000449
• NIH Device Record Key: 7e43564b-5527-4b78-9dac-18c1260cf6a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: bFed™
• Version Model Number: SK-2001
• Catalog Number: SK-2001
• Company DUNS: 080494259
• Company Name: U DELIVER MEDICAL L.L.C.
• Device Count: 7
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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@udelivermedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867622000449 [Primary]
GS1	00867622000463 [Unit of Use]

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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-02

On-Brand Devices [bFed™]

• 00867622000456: bFed Refill kit containing 10 Large Cap Bolink™ Gravity Feeding Sets with ENFit® Connector (
• 00867622000449: bFed Starter kit containing 5 Large Cap Bolink™ Gravity Feeding Sets with ENFit® Connector (