DEVICE: Sunflower Warmer, Stand AC120V (04942962615761)

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Device Identifier (DI) Information

Sunflower Warmer, Stand AC120V
61576
61576
ATOM MEDICAL CORPORATION
04942962615761
GS1
1
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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Open infant incubator A mains electricity (AC-powered) unit that functions similar to a standard infant incubator but is open, having low side walls and no top enclosure, giving instant access to the infant. Such infants are not premature but suffer from disorders where intensive care is required. This device is equipped with overhead heating lamp(s), oxygen therapy flowmeter, gas mixer, suction system, facilities for infusion pumps, and other equipment. The main difference between this device and a closed infant incubator is the inability of this device to regulate the oxygen environment surrounding the occupant.
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FDA Product Code

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Product Code Product Code Name
FMT Warmer, Infant Radiant
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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 18 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Width: 73 Centimeter
Height: 184 Centimeter
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Device Status

In Commercial Distribution
December 27, 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

[?]
9999999999
matsumoto@atom-ami.co.jp
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