weony - Weony (ShenZhen) Technology Co., Ltd.

Duns Number:419815000

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More Product Details

Catalog Number

-

Brand Name

weony

Version/Model Number

WBP108

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

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

b40df262-c438-4f1d-baa3-a658285c75d0

Public Version Date

October 19, 2022

Public Version Number

1

DI Record Publish Date

October 11, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WEONY (SHENZHEN) TECHNOLOGY CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2