DEVICE: neoBLUE Compact LED Phototherapy System (00382830016773)
Device Identifier (DI) Information
neoBLUE Compact LED Phototherapy System
neoBLUE compact
In Commercial Distribution
018000, 019051, 019001, 019011
NATUS MEDICAL INCORPORATED
neoBLUE compact
In Commercial Distribution
018000, 019051, 019001, 019011
NATUS MEDICAL INCORPORATED
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
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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 |
Sterilization
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
f309ec9b-0981-49c1-9a23-24d44ee79a15
July 06, 2018
3
April 14, 2017
July 06, 2018
3
April 14, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-303-0306
technical_service@natus.com
technical_service@natus.com