AccessGUDID - DEVICE: UVBioTek (B343B3200)

GUDID

Device Identifier (DI) Information

Brand Name: UVBioTek
Version or Model: 3200B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3200B
Company Name: Medtek Lighting Corporation

Primary DI Number: B343B3200
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002692106 *Terms of Use

Device Description: Phototherapy Unit. UVB Narrowband. 4 connected panels, attached to a wall, wrap around patient. 32 Lamps, each 72" in height. Clinic use only.

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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FTC	Light, Ultraviolet, Dermatological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051330	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
Area/Surface Area: 5740 Square inch
Weight: 500 Pound

Device Record Status

Public Device Record Key: 03926f7d-5e24-4f26-bbc5-ed7fce3555fb
Public Version Date: December 21, 2018
Public Version Number: 4
DI Record Publish Date: February 09, 2017