LMI BILIARY CATHETER

GUDID B3803FBIL400

LUCAS MEDICAL INC

Biliary drainage catheter Biliary drainage catheter

• Primary Device ID: B3803FBIL400
• NIH Device Record Key: 0835db8a-8a3b-4793-8aae-6bebe86cb856
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LMI BILIARY CATHETER
• Version Model Number: 3FBIL40
• Company DUNS: 878198993
• Company Name: LUCAS MEDICAL INC
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B3803FBIL400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955126

FDA Product Code

• FGE: Catheter, Biliary, Diagnostic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[B3803FBIL400]

Ethylene Oxide

[B3803FBIL400]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-02

On-Brand Devices [LMI BILIARY CATHETER]

• B3807FBIL400: 7FBIL40
• B3807FBIL230: 7FBIL23
• B3806FBIL400: 6FBIL40
• B3806FBIL230: 6FBIL23
• B3805FBIL400: 5FBIL40
• B3805FBIL230: 5FBIL23
• B3804FBIL400: 4FBIL40
• B3804FBIL230: 4FBIL23
• B3803FBIL400: 3FBIL40
• B3803FBIL230: 3FBIL23