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
04942962613057
GS1
November 06, 2024
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

[?]

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.
Active false
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FDA Product Code

[?]
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

[?]
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: 44 Centimeter
Width: 95 Centimeter
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Device Record Status

d64fa9ce-6a33-436d-9d67-f327bcba6629
November 15, 2024
5
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

[?]
+81488533661
hitoshi.hayashi@atomed.co.jp
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