AGE - Arm type blood pressure monitor, It can can - AGELESS HEALTH INDUSTRIAL LIMITED

Duns Number:421298453

Device Description: Arm type blood pressure monitor, It can can correctly measure arterial blood pressure, mus Arm type blood pressure monitor, It can can correctly measure arterial blood pressure, must take off the coat for measurement, The cuff of the sphygmomanometer is attached to the left arm,It is very suitable for use in the family

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More Product Details

Catalog Number

-

Brand Name

AGE

Version/Model Number

BA-813

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

K123882

Product Code Details

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

2b3bc132-feb8-4c8a-992e-ea16337d7f1f

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

October 29, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AGELESS HEALTH INDUSTRIAL LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 19