AccessGUDID - DEVICE: BLU-U® Blue Light Photodynamic Therapy Illuminator (M706417011)

GUDID

Device Identifier (DI) Information

Brand Name: BLU-U® Blue Light Photodynamic Therapy Illuminator
Version or Model: 4170-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4170-1
Company Name: DUSA PHARMACEUTICALS INC.

Primary DI Number: M706417011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 109234786 *Terms of Use

Device Description: The 4170-1 is the Head Assembly component of the BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170 (BLU-U). The BLU-U Head Assembly (4170-1) is assembled for use only with the BLU-U Post Assembly (4170-2) and the BLU-U Base Assembly (4170-3). The BLU-U is a compact light source designed to provide a uniform distribution the blue light. The BLU-U Head Assembly (4170-1) is mounted on a Post Assembly (4170-2) and a Base Assembly (4170-3). The BLU-U has a built-in power output monitoring and diagnostic system, as well as a system timer used to set the light dose delivered to a patient.

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:	Yes
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?
59822	Skin photodynamic therapy/phototherapy lamp	A portable, mains electricity (AC-powered) lamp intended to emit low-level narrow-band (LLNB) red light (e.g., 600-650nm) and blue light (e.g., 415-440nm) either separately or simultaneously for photodynamic therapy (PDT) applications (with photosensitizing agent) to treat skin disorders such as actinic keratosis and non-melanoma skin cancer, and for phototherapy applications (through modification of skin metabolism) to treat skin complaints such as acne, rosacea and sun spots. It uses light-emitting diodes (LEDs) to produce a heatless light source which may be used for treatment at multiple anatomical sites. It is intended to be used by a healthcare professional in a clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVF	System, Laser, Photodynamic Therapy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P990019	001

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
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
Storage Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dccab8d4-ba2c-4519-9246-b3a30f1661e5
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 15, 2014