DEVICE: V-808 Main Unit Only(120 V) (04942962615228)

Device Identifier (DI) Information

V-808 Main Unit Only(120 V)
61522
In Commercial Distribution
61522
ATOM MEDICAL CORPORATION
04942962615228
GS1

1
690632047 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Transport infant incubator An electrically-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 is typically on wheels and also designed for transporting infants either outside or within the healthcare facility. It typically consists of a clear removable plastic hood with a mattress and operates using mains electricity (AC-powered) when not in use for transportation. During transport, it is connected to an ambulance electrical outlet or is battery-powered from a battery pack.
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FDA Product Code

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Product Code Product Code Name
FPL Incubator, Neonatal Transport
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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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
Handling Environment Temperature: between 10 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Depth: 49 Centimeter
Width: 98 Centimeter
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Device Record Status

83dedcf1-a5af-4fd5-85d8-4ad02824431b
March 29, 2018
2
September 21, 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
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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9999999999
matsumoto@atom-ami.co.jp
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