Pupilometer - Measure the distance between the pupils of human - Chongqing Yeasn Science & Technology Co.,Ltd.

Duns Number:547954649

Device Description: Measure the distance between the pupils of human eye.

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More Product Details

Catalog Number

-

Brand Name

Pupilometer

Version/Model Number

HX-400

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

HLH

Product Code Name

Pupillometer, Manual

Device Record Status

Public Device Record Key

b5678845-bf3e-4820-abf1-00e86a326225

Public Version Date

October 30, 2020

Public Version Number

1

DI Record Publish Date

October 22, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CHONGQING YEASN SCIENCE & TECHNOLOGY CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 20
2 A medical device with a moderate to high risk that requires special controls. 1