AccessGUDID - DEVICE: National Biological Corporation (00816878020152)

GUDID

Device Identifier (DI) Information

Brand Name: National Biological Corporation
Version or Model: UVB-082
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NATIONAL BIOLOGICAL CORPORATION

Primary DI Number: 00816878020152
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 046198420 *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):	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?
34669	Ultraviolet phototherapy unit, home-use	A mains electricity (AC-powered), portable, device that includes a lamp which emits light in the ultraviolet (UV) band intended to treat dermatological disorders (e.g., psoriasis, dermatitis) in the home.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FTC	Light, Ultraviolet, Dermatological
IOB	Lamp, Infrared, Non Heating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K903660	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
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e05bdfa7-9f4e-4f41-9a9d-b97c4c6835a1
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: March 10, 2017