LMI BILUMEN BILIARY CATHETER DISTAL

GUDID B3805FBBIR540D0

LUCAS MEDICAL INC

Biliary drainage catheter

• Primary Device ID: B3805FBBIR540D0
• NIH Device Record Key: 30edea2b-6adc-4edc-8275-1527468d9246
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LMI BILUMEN BILIARY CATHETER DISTAL
• Version Model Number: 5FBBIR540D
• 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	B3805FBBIR540D0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955126

FDA Product Code

• FGE: Stents, Drains And Dilators For The Biliary Ducts

Sterilization

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

[B3805FBBIR540D0]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-23
• Device Publish Date: 2019-07-15

On-Brand Devices [LMI BILUMEN BILIARY CATHETER DISTAL]

• B3807FBBIR740D0: 7FBBIR740D
• B3806FBBIR640D0: 6FBBIR640D
• B3805FBBIR540D0: 5FBBIR540D
• B3804FBBIR440D0: 4FBBIR440D