Catalog Number

-

Brand Name

唐长银

Version/Model Number

HS-20A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

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

K092245,K092245

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

f54fac76-7628-4cc0-866a-b5675335e6af

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-