Catalog Number

-

Brand Name

CIEKAA

Version/Model Number

B21H

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

August 26, 2026

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K200437,K200437

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

16b5c89c-b076-4d31-8e29-0c41e1bc8500

Public Version Date

September 06, 2021

Public Version Number

1

DI Record Publish Date

August 27, 2021

Package DI Number

16927709421022

Quantity per Package

20

Contains DI Package

06927709421025

Package Discontinue Date

August 25, 2026

Package Status

In Commercial Distribution

Package Type

Carton