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
00382830016773
GS1

1
962519208 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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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.
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FDA Product Code

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Product Code Product Code Name
LBI Unit, Neonatal Phototherapy
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K160745 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

f309ec9b-0981-49c1-9a23-24d44ee79a15
July 06, 2018
3
April 14, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
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Yes
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Customer Contact

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1-800-303-0306
technical_service@natus.com
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