DEVICE: Atom Infant Incubator 100 AC120V w/o O2 Controller Unit (04942962616027)
Device Identifier (DI) Information
Atom Infant Incubator 100 AC120V w/o O2 Controller Unit
61602
In Commercial Distribution
61602
ATOM MEDICAL CORPORATION
61602
In Commercial Distribution
61602
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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36025 | Conventional infant incubator |
A mains electricity (AC-powered) unit designed to provide an enclosed controlled environment to maintain appropriate temperature and humidity levels mainly for premature infants and other newborns who cannot effectively regulate their body temperature. It typically consists of a clear removable plastic hood with a mattress. It typically includes a means to warm the infant such as providing heated air (either by natural flow or forced) or through a warm water mattress; temperature controls that work automatically either by measuring the air temperature or through a temperature sensor attached to the infant skin; and humidity controls. The device is intended to remain in a hospital ward.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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FMZ | Incubator, Neonatal |
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 20 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Depth: 68 Centimeter |
Width: 119 Centimeter |
Device Record Status
d3781a8a-5522-4e40-84a4-7ca937a9ce78
January 29, 2019
3
September 21, 2016
January 29, 2019
3
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