AccessGUDID - DEVICE: neoBLUE Compact LED Phototherapy System (00382830016773)

GUDID

Device Identifier (DI) Information

Brand Name: neoBLUE Compact LED Phototherapy System
Version or Model: neoBLUE compact
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 018000, 019051, 019001, 019011
Company Name: NATUS MEDICAL INCORPORATED

Primary DI Number: 00382830016773
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962519208 *Terms of Use

Device Description: The neoBLUE compact LED Phototherapy System is a portable phototherapy light that delivers a narrow band of high-intensity blue light via light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia. The neoBLUE® compact LED Phototherapy System can be used in three different configurations: the light source (light) can be used alone, with the neoBLUE compact arm, and with the neoBLUE compact roll stand.

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):	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?
35239	Overhead infant phototherapy unit	A mains electricity (AC-powered) device designed to emit a blue light in the visible wavelength of around 425-475 nm to treat neonatal jaundice (hyperbilirubinemia). It consists of an overhead lamp consisting of several, daylight, cool white, blue, or special blue fluorescent light tubes and a Plexiglas shield placed between the phototherapy lights and the newborn to filter out ultraviolet (UV) radiation. Exposure to this device will alter the bilirubin through photo-oxidation, and configurational and structural isomerization, allowing the body to dispose of it naturally. It will typically have a built-in timer, but some may have a separate timer unit connected.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LBI	Unit, Neonatal Phototherapy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160745	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 Humidity: between 5 and 95 Percent (%) Relative Humidity
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -30 and 50 Degrees Celsius
Handling Environment Temperature: between 5 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f309ec9b-0981-49c1-9a23-24d44ee79a15
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 14, 2017