Catalog Number

-

Brand Name

Changke Connect

Version/Model Number

GCF1202

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K191253

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

5e93f2d0-2241-45d5-948f-d987d5f4af5e

Public Version Date

March 14, 2022

Public Version Number

1

DI Record Publish Date

March 04, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-