DEVICE: Semi-Iris Access Port Cover(20 pcs/pkg) (04942962608619)

Device Identifier (DI) Information

Semi-Iris Access Port Cover(20 pcs/pkg)
60861
In Commercial Distribution
60861
ATOM MEDICAL CORPORATION
04942962608619
GS1

20
690632047 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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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
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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

f491f899-74fa-4d9f-ae1c-0e831969ca80
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: 84942962608615 CLOSE

Direct Marking (DM)

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Yes
No
None
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Production Identifier(s) in UDI

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Yes
No
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No CLOSE

Customer Contact

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9999999999
matsumoto@atom-ami.co.jp
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