LumenCare Azure

GUDID 08717213056770

LumenCare Azure Set 5F, 140cm

Nucletron B.V.

Bronchial brachytherapy system applicator, remote-afterloading

• Primary Device ID: 08717213056770
• NIH Device Record Key: 87b82dc7-f72a-4d1d-acaa-d0dd36026f03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LumenCare Azure
• Version Model Number: 110691-02
• Company DUNS: 415269930
• Company Name: Nucletron B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(770)300-9725
• Email: info.america@elekta.com
• Phone: +1(770)300-9725
• Email: info.america@elekta.com
• Phone: +1(770)300-9725
• Email: info.america@elekta.com

Device Dimensions

• Length: 140 Centimeter
• Catheter Gauge: 5 French
• Length: 140 Centimeter
• Catheter Gauge: 5 French
• Length: 140 Centimeter
• Catheter Gauge: 5 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717213056770 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132874

FDA Product Code

• JAQ: System, applicator, radionuclide, remote-controlled

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-25
• Device Publish Date: 2020-05-16

On-Brand Devices [LumenCare Azure]

• 08717213056770: LumenCare Azure Set 5F, 140cm
• 08717213056763: LumenCare Azure Set 5F, 150cm
• 08717213054332: LumenCare Azure 5F, 150cm
• 08717213055735: LumenCare Azure 5F, 140cm