DEVICE: Atom Phototherapy Analyzer Ⅱ (04942962684484)

Device Identifier (DI) Information

Atom Phototherapy Analyzer Ⅱ
68448
In Commercial Distribution
68448
ATOM MEDICAL CORPORATION
04942962684484
GS1

1
690632047 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
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
Photometer, reflectance An instrument that measures the amount of light emitted by a light source, e.g., a light-emitting diode, as reflected from a sample in order to determine the concentration of an element. The device usually contains a photodiode for light detection.
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FDA Product Code

[?]
Product Code Product Code Name
JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

f1902d15-4d1b-4725-b62c-9cfdad1a5e6c
March 29, 2018
2
September 21, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

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