DEVICE: COMPUTERIZED VISION TESTER (06971821401021)

Device Identifier (DI) Information

COMPUTERIZED VISION TESTER
CV-7600
In Commercial Distribution

Ningbo Ming Sing Optical R & D Co., Ltd.
06971821401021
GS1

1
654386890 *Terms of Use
The product is used for subjectively checking eye sight ,and provide diagnosis for ophthalmologist It belongs to non-invasive device,and it may be contacted on patient’s face for short time about several minutes. Just a single dial enabling every operation. Ergonomic switch sheet layout. Easy touch buttons for blind operation. The contents of chart display to be confirmed even in examination in the dark room. The CV-7600 is a computerized autophoropter,including a phoropter head, a controller and a power adapter.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
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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?
35299 Phoropter
An ophthalmic device intended to be placed in front of a patient's eyes to measure the refractive error of the eye (the inaccuracies of focusing light upon the retina) during an ophthalmic examination, typically to determine a patient's prescription for glasses. It typically consists of two mounted, disk-like housings which contain lenses of different characteristics. It is designed such that the optometrist can change the lenses and other settings while asking the patient to read an eye chart and to provide subjective feedback on which settings give best vision. The setting changes may be manual or automated.
Obsolete false
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FDA Product Code

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Product Code Product Code Name
HIT Tester, Color Vision
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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

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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

dcf91646-712b-4ba4-8790-12b8277958e8
December 21, 2020
2
December 02, 2019
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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
No
No CLOSE

Customer Contact

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+86057487305541
2583438849@qq.com
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