DEVICE: Foresee Home™ (07290017803005)

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Device Record History
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Device Identifier (DI) Information
Foresee Home™
V2
In Commercial Distribution
901F001
NOTAL VISION LTD
07290017803005
GS1

1
532596533 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
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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?
59259 Macular pigment analyser
A mains electricity (AC-powered) computerized device designed for the noninvasive in vivo measurement of macular pigment optical density (MPOD) used in the evaluation of age-related macular degeneration (AMD). It is a portable unit that includes a light-emitting diode (LED) board intended to evaluate a patient who looks down an ocular lens and responds to a flickering spot (heterochromatic flicker photometry); after a series of presentations a value for the MPOD is calculated and displayed. The device may be used in association with dedicated software installed on a personal computer; it may be used in healthcare facilities or in the home.
Active false
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FDA Product Code

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Product Code Product Code Name
HPT Perimeter, Automatic, Ac-Powered
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K091579 000
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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
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
7d723950-776b-40cb-8892-e31e5ee44e8b
April 09, 2021
1
April 01, 2021
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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
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Customer Contact

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No Customer Contact currently defined
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