AccessGUDID - DEVICE: Kalfasun (B5331165150)

GUDID

Device Identifier (DI) Information

Brand Name: Kalfasun
Version or Model: Kalfasun 1540 FDA
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 116515
Company Name: BLV Licht- und Vakuumtechnik GmbH

Primary DI Number: B5331165150
Issuing Agency: HIBCC
Commercial Distribution End Date: November 29, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 315736603 *Terms of Use

Device Description: No description.

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):	No
Over the Counter (OTC):	Yes
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?
46387	Ultraviolet tanning device	A mains electricity (AC-powered) lamp or bed/booth with lamps designed to provide radiation in the ultraviolet spectrum for tanning the skin. This device is used for cosmetic purposes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LEJ	Booth, Sun Tan

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: d0d3ccc4-1137-444b-b333-5f334f072686
Public Version Date: January 20, 2025
Public Version Number: 2
DI Record Publish Date: June 13, 2023