DAAVLIN 808HO0006CT5ND

GUDID B280808HO0006CT5ND01

7 Ser CT 311-6 CE 120-240V 50/60Hz

DAAVLIN DISTRIBUTING CO., THE

Ultraviolet phototherapy unit, professional

• Primary Device ID: B280808HO0006CT5ND01
• NIH Device Record Key: 935fa32a-57cd-405b-b01f-11d557d99b1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DAAVLIN
• Version Model Number: 7 SERIES
• Catalog Number: 808HO0006CT5ND
• Company DUNS: 056696347
• Company Name: DAAVLIN DISTRIBUTING CO., THE
• Device Count: 1
• DM Exempt: true
• 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: true
• 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: XX@XX.XX
• Phone: 1-800-322-8546
• Email: XX@XX.XX
• Phone: 1-800-322-8546
• Email: XX@XX.XX
• Phone: 1-800-322-8546
• Email: XX@XX.XX
• Phone: 1-800-322-8546
• Email: XX@XX.XX
• Phone: 1-800-322-8546
• Email: XX@XX.XX
• Phone: 1-800-322-8546
• Email: XX@XX.XX
• Phone: 1-800-322-8546
• Email: XX@XX.XX
• Phone: 1-800-322-8546
• Email: XX@XX.XX
• Phone: 1-800-322-8546
• Email: XX@XX.XX
• Phone: 1-800-322-8546
• Email: XX@XX.XX
• Phone: 1-800-322-8546
• Email: XX@XX.XX
• Phone: 1-800-322-8546
• Email: XX@XX.XX
• Phone: 1-800-322-8546
• Email: XX@XX.XX
• Phone: 1-800-322-8546
• Email: XX@XX.XX
• Phone: 1-800-322-8546
• Email: XX@XX.XX

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B280808HO0006CT5ND01 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050695

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: 2021-12-09
• Device Publish Date: 2021-12-01

On-Brand Devices [DAAVLIN]

• B280A0005400: LEVIA, NB UVB
• B280A0003000: LEVIA, UVB SELECT
• B280951CTLS0: LIGHT SOURCE, LUMERA 100-125V
• B280935ML24000PC0: ML24000 SMART TOUCH 130V 60HZ 3PH 100AMP
• B280935ML240000: ML24000 130V 60HZ 3PH 100AMP
• B280935DPNBDT600: DIGITAL DERMAPAL NB 120V 60HZ
• B280935DPBDT600: DIGITAL DERMAPAL BB 120V 60HZ
• B280935DPADT600: DIGITAL DERMAPAL UVA 120V 60HZ
• B280865NL4800X0: NEOLUX PREM X 350-48
• B280865NL4800PC0: NEOLUX PREM PC 350-48
• B280865NL4800MMPC0: NEOLUX PREM MMPC 350-48
• B280865NL4000X0: NEOLUX PREM X 350-40
• B280865NL4000PC0: NEOLUX PREM PC 350-40
• B280865NL4000MMPC0: NEOLUX PREM MMPC 350-40
• B280865NL2424X0: NEOLUX PREM X 311/350-24/24
• B280865NL2424PC0: NEOLUX PREM PC 311/350-24/24
• B280865NL2424MMPC0: NEOLUX PREM MMPC 311/350-24/24
• B280865NL2020X0: NEOLUX PREM X 311/350-20/20
• B280865NL2020PC0: NEOLUX PREM PC 311/350-20/20
• B280865NL2020MMPC0: NEOLUX PREM MMPC 311/350-20/20
• B280865NL0048X0: NEOLUX PREM X 311-48
• B280865NL0048PC0: NEOLUX PREM PC 311-48
• B280865NL0048MMPC0: NEOLUX PREM MMPC 311-48
• B280865NL0040X0: NEOLUX PREM X 311-40
• B280865NL0040PC0: NEOLUX PREM PC 311-40
• B280865NL0040MMPC0: NEOLUX PREM MMPC 311-40
• B280864NL4800X0: NEOLUX X 350-48
• B280864NL4800PC0: NEOLUX PC 350-48
• B280864NL4800MMPC0: NEOLUX MMPC 350-48
• B280864NL4000X0: NEOLUX X 350-40
• B280864NL4000PC0: NEOLUX PC 350-40
• B280864NL4000MMPC0: NEOLUX MMPC 350-40
• B280864NL2424X0: NEOLUX X 311/350-24/24
• B280864NL2424PC0: NEOLUX PC 311/350-24/24
• B280864NL2424MMPC0: NEOLUX MMPC 311/350-24/24
• B280864NL2020X0: NEOLUX X 311/350-20/20
• B280864NL2020PC0: NEOLUX PC 311/350-20/20
• B280864NL2020MMPC0: NEOLUX MMPC 311/350-20/20
• B280864NL0048X0: NEOLUX X 311-48
• B280864NL0048PC0: NEOLUX PC 311-48
• B280864NL0048MMPC0: NEOLUX MMPC 311-48
• B280864NL0040X0: NEOLUX X 311-40
• B280864NL0040PC0: NEOLUX PC 311-40
• B280864NL0040MMPC0: NEOLUX MMPC 311-40
• B280862PM0048PC60: 3 SERIES PC 311-48 W MLSCN 208-240V 60HZ
• B280861PH4800X60: 3 SERIES X 350-48 208-240V 60HZ
• B280861PH4800SP60: 3 SERIES SP 350-48 208-240V 60HZ
• B280861PH4800PC60: 3 SERIES PC 350-48 208-240V 60HZ
• B280861PH4800MMPC60: 3 SERIES MULTI MACHINE PC 350-48 208-240V 60HZ
• B280861PH3612X60: 3 SERIES X 305/350-12/36 208-240V 60HZ