AccessGUDID - DEVICE: DAAVLIN (B280807QS0020T60)

GUDID

Device Identifier (DI) Information

Brand Name: DAAVLIN
Version or Model: 4 SERIES
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 807QS0020T6
Company Name: DAAVLIN DISTRIBUTING CO., THE

Primary DI Number: B280807QS0020T60
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 056696347 *Terms of Use

Device Description: 4 SERIES T 311-20 100-125V 50/60HZ

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Ultraviolet phototherapy unit	A mains electricity (AC-powered) device with special lamps that emit ultraviolet B (UVB), or UVB and ultraviolet A (UVA) radiation intended 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).

GMDN Preferred Term Name

GMDN Definition

Ultraviolet phototherapy unit

A mains electricity (AC-powered) device with special lamps that emit ultraviolet B (UVB), or UVB and ultraviolet A (UVA) radiation intended 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).

FDA Product Code

[?]

Product Code	Product Code Name
FTC	Light, Ultraviolet, Dermatological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111172	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 63f5059e-8fe6-440b-a1a5-199c79732581
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016