DEVICE: neoBLUE (00382830053198)

Device Identifier (DI) Information

neoBLUE
Cozy
In Commercial Distribution
001354
NATUS MEDICAL INCORPORATED
00382830053198
GS1

1
962519208 *Terms of Use
The neoBLUE cozy™ Phototherapy System is a mobile phototherapy light that delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia. The neoBLUE cozy light was designed for use within a patient enclosure, positioned under the baby
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Blanket/pad infant phototherapy unit A device designed to emit a blue light in the visible wavelength of around 425-475 nm to treat neonatal jaundice (or hyperbilirubinemia). It consists of a fibreoptic-light source that connects through a flexible fibreoptic cable to a transparent blanket-like wrap or pad which emits the light and covers or encloses the neonate's body. Exposure to this device will alter the bilirubin through photo oxidation and configurational and structural isomerization allowing the body function to dispose of it naturally. This device can be suitable for home-use.
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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 [?]
K051869 000
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Sterilization

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

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Storage and Handling
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 20 and 30 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -30 and 50 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Length: 17.5 Inch
Width: 8.5 Inch
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Device Record Status

de5522ec-2616-420c-b5f0-696e87988c8a
July 06, 2018
3
December 22, 2016
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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
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None
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Production Identifier(s) in UDI

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Customer Contact

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