LMI BILUMEN IRRIGATION (PROXIMAL) ARTERIAL EMBOLEC

GUDID B3805FIRR080P0

LUCAS MEDICAL INC

Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided Intravascular occluding balloon catheter, image-guided

• Primary Device ID: B3805FIRR080P0
• NIH Device Record Key: 46b01755-71d7-40c8-820c-40f047b11080
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LMI BILUMEN IRRIGATION (PROXIMAL) ARTERIAL EMBOLEC
• Version Model Number: 5FIRR080P
• 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	B3805FIRR080P0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955499

FDA Product Code

• MJN: Catheter, Intravascular Occluding, Temporary

Sterilization

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

[B3805FIRR080P0]

Ethylene Oxide

[B3805FIRR080P0]

Ethylene Oxide

[B3805FIRR080P0]

Ethylene Oxide

[B3805FIRR080P0]

Ethylene Oxide

[B3805FIRR080P0]

Ethylene Oxide

[B3805FIRR080P0]

Ethylene Oxide

[B3805FIRR080P0]

Ethylene Oxide

[B3805FIRR080P0]

Ethylene Oxide

[B3805FIRR080P0]

Ethylene Oxide

[B3805FIRR080P0]

Ethylene Oxide

[B3805FIRR080P0]

Ethylene Oxide

[B3805FIRR080P0]

Ethylene Oxide

[B3805FIRR080P0]

Ethylene Oxide

[B3805FIRR080P0]

Ethylene Oxide

[B3805FIRR080P0]

Ethylene Oxide

[B3805FIRR080P0]

Ethylene Oxide

[B3805FIRR080P0]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-21
• Device Publish Date: 2016-09-06

On-Brand Devices [LMI BILUMEN IRRIGATION (PROXIMAL) ARTERIAL EMBOLEC]

• B3807FIRR080P0: 7FIRR080P
• B3807FIRR040P0: 7FIRR040P
• B3806FIRR080P0: 6FIRR080P
• B3806FIRR040P0: 6FIRR040P
• B3805FIRR080P0: 5FIRR080P
• B3805FIRR040P0: 5FIRR040P
• B3804FIRR080P0: 4FIRR080P
• B3804FIRR040P0: 4FIRR040P