Veloxion 1327

GUDID 00860011104414

Veloxion Fluid Control Set

Aulea Medical Inc.

Resectoscope

• Primary Device ID: 00860011104414
• NIH Device Record Key: fa7fd37d-af5c-418d-b3e0-762b411dfa73
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Veloxion
• Version Model Number: 1327
• Catalog Number: 1327
• Company DUNS: 119365804
• Company Name: Aulea 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: false
• Expiration Date: true
• 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: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com
• Phone: 9255330018
• Email: qa@auleamed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011104414 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230205

FDA Product Code

• FJL: Resectoscope

Sterilization

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

[00860011104414]

Radiation Sterilization

[00860011104414]

Radiation Sterilization

[00860011104414]

Radiation Sterilization

[00860011104414]

Radiation Sterilization

[00860011104414]

Radiation Sterilization

[00860011104414]

Radiation Sterilization

[00860011104414]

Radiation Sterilization

[00860011104414]

Radiation Sterilization

[00860011104414]

Radiation Sterilization

[00860011104414]

Radiation Sterilization

[00860011104414]

Radiation Sterilization

[00860011104414]

Radiation Sterilization

[00860011104414]

Radiation Sterilization

[00860011104414]

Radiation Sterilization

[00860011104414]

Radiation Sterilization

[00860011104414]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-13
• Device Publish Date: 2025-01-03

On-Brand Devices [Veloxion]

• 00860011104452: Veloxion Roll Stand
• 00860011104445: Veloxion Controller Kit
• 00860011104483: Tissue Catch
• 00860011104421: Waste Management Tubing
• 00860011104414: Veloxion Fluid Control Set
• 00860011104407: Veloxion Resectoscope