DEVICE: V-707 with Power Pack(100-120V) (04942962613057)
Device Identifier (DI) Information
V-707 with Power Pack(100-120V)
61305
Not in Commercial Distribution
61305
ATOM MEDICAL CORPORATION
61305
Not in Commercial Distribution
61305
ATOM MEDICAL CORPORATION
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
No | |
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No | |
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No |
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? |
---|---|---|---|---|
35121 | Transport infant incubator |
An electrically-powered unit designed to provide an enclosed controlled environment to maintain appropriate temperature, and in some cases humidity levels, mainly for premature infants and other newborns who cannot effectively regulate their body temperature; it is typically on wheels and is designed for transporting infants either outside or within the healthcare facility. It typically consists of a clear removable/openable plastic hood with a mattress and operates using mains electricity (AC-powered) when not in use for transportation; some types may be supplied with an equipment rack. During transport, it is connected to an ambulance electrical outlet or is battery-powered.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FPL | Incubator, Neonatal Transport |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
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: 44 Centimeter |
Width: 95 Centimeter |
Device Record Status
d64fa9ce-6a33-436d-9d67-f327bcba6629
November 15, 2024
5
September 21, 2016
November 15, 2024
5
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 |
---|---|---|---|---|---|
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
[?]
+81488533661
hitoshi.hayashi@atomed.co.jp
hitoshi.hayashi@atomed.co.jp