DEVICE: BILI-THERAPY Pad Type (04942962603706)
Device Identifier (DI) Information
BILI-THERAPY Pad Type
60370
In Commercial Distribution
60370
ATOM MEDICAL CORPORATION
60370
In Commercial Distribution
60370
ATOM MEDICAL CORPORATION
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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33791 | 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 light source that connects to a 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. It is intended for use in the home and a clinical setting.
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FDA Product Code
[?]Product Code | Product Code Name |
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LBI | Unit, Neonatal Phototherapy |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between 10 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Depth: 220 Millimeter |
Width: 150 Millimeter |
Device Record Status
9e5bbd99-f6c4-4af8-b688-2a92de9b7dfb
February 16, 2024
4
September 21, 2016
February 16, 2024
4
September 21, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
+81 488533661
hitoshi.hayashi@atomed.co.jp
hitoshi.hayashi@atomed.co.jp