C0MFIER - Blood Pressure Monitor - Shenzhen Jamr Medical Technology Co., Ltd.

Duns Number:421350239

Device Description: Blood Pressure Monitor

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More Product Details

Catalog Number

/

Brand Name

C0MFIER

Version/Model Number

B15

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K200437,K200437

Product Code Details

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

100f0497-4f07-4347-a7b5-8a204dd2f745

Public Version Date

September 30, 2021

Public Version Number

1

DI Record Publish Date

September 22, 2021

Additional Identifiers

Package DI Number

16927709415137

Quantity per Package

20

Contains DI Package

06927709415130

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"SHENZHEN JAMR MEDICAL 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. 70