DAAVLIN

Basic Information

• Brand Name: DAAVLIN
• Primary DI: B280807OS0004X60
• Version / Model: 1 SERIES
• Catalog Number: 807OS0004X6
• Company Name: DAAVLIN DISTRIBUTING CO., THE
• Labeler DUNS: 056696347
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 4
• Public Version Date: 2018-12-21
• Public Version Status: Update
• Public Device Record Key: 321e2680-9550-4d4e-9d8d-ae10b42b2a36

Device Description

1 SERIES X 311-4 100-125V 50/60HZ

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FTC	Light, Ultraviolet, Dermatological	General, Plastic Surgery	878.4630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35149	Ultraviolet phototherapy unit, professional	A mains electricity (AC-powered) device with special lamps that emit ultraviolet B (UVB), or UVB and ultraviolet A (UVA) radiation intended to be used by a healthcare professional to treat a variety of dermatological disorders (e.g., psoriasis). The device is typically designed as a flat surface for lying with an overhead lamp(s), or as a chamber/cabinet, in which the patient stands, with interior walls lined with ultraviolet (UV) light tubes to allow full-body exposure and an even distribution of UV radiation. The device intended use may include psoralen + UVA therapy (oral administration of psoralen and subsequent exposure to UVA) (PUVA).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B280807OS0004X60	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K100378	000