Dermalume

GUDID 00850054882042

UVB-090

DAAVLIN DISTRIBUTING CO., THE

Ultraviolet phototherapy unit, professional

• Primary Device ID: 00850054882042
• NIH Device Record Key: 6e53bcd2-c530-4ca9-8f70-e398546c09e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dermalume
• Version Model Number: Dermalume
• Company DUNS: 056696347
• Company Name: DAAVLIN DISTRIBUTING CO., THE
• 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: false
• Lot Batch: false
• Serial Number: true
• 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(800)322-8546
• Email: info@daavlin.com
• Phone: +1(800)322-8546
• Email: info@daavlin.com
• Phone: +1(800)322-8546
• Email: info@daavlin.com
• Phone: +1(800)322-8546
• Email: info@daavlin.com
• Phone: +1(800)322-8546
• Email: info@daavlin.com
• Phone: +1(800)322-8546
• Email: info@daavlin.com
• Phone: +1(800)322-8546
• Email: info@daavlin.com
• Phone: +1(800)322-8546
• Email: info@daavlin.com
• Phone: +1(800)322-8546
• Email: info@daavlin.com
• Phone: +1(800)322-8546
• Email: info@daavlin.com
• Phone: +1(800)322-8546
• Email: info@daavlin.com
• Phone: +1(800)322-8546
• Email: info@daavlin.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850054882042 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233811

FDA Product Code

• FTC: LIGHT, ULTRAVIOLET, DERMATOLOGICAL

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: 2024-12-20
• Device Publish Date: 2024-12-12

Devices Manufactured by DAAVLIN DISTRIBUTING CO., THE

• 00810182930930 - DAAVLIN: 2024-12-23 PP4000XL COMBO PC 20/20L
• 00810182930008 - DAAVLIN: 2024-12-20 P100 NBUVB DT 1L
• 00810182930015 - DAAVLIN: 2024-12-20 P100 NBUVB DT 1L
• 00810182930022 - DAAVLIN: 2024-12-20 P100 NBUVB DT 1L
• 00810182930039 - DAAVLIN: 2024-12-20 P100 BBUVB DT 1L
• 00810182930046 - DAAVLIN: 2024-12-20 P100 UVA DT 1L
• 00810182930053 - DAAVLIN: 2024-12-20 P100 UVA DT 1L
• 00810182930060 - DAAVLIN: 2024-12-20 P100 DT 2L