DEVICE: neoBLUE (00382830015516)

Device Identifier (DI) Information

neoBLUE
Blanket Disposable Mattress Cover Large
In Commercial Distribution
005989
NATUS MEDICAL INCORPORATED
00382830015516
GS1

50
962519208 *Terms of Use
neoBLUE Blanket Large Disposble Cover
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

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 [?]
K103589 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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Length: 19.85 Inch
Width: 10.53 Inch
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Device Record Status

e2e535e1-98ff-4bdd-beb0-c7a57f88aba0
July 06, 2018
3
December 29, 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: 00382830053211 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

[?]
1-800-303-0306
Technical_service@natus.com
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