Walgreens - Wrist type blood pressure monitor - HEALTH & LIFE CO., LTD.

Duns Number:657836743

Device Description: Wrist type blood pressure monitor

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More Product Details

Catalog Number

-

Brand Name

Walgreens

Version/Model Number

WGNBPW-930BT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

K160557,K160557

Product Code Details

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

9c6982b8-e430-4e6b-b5c4-654ea1cf75d8

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

July 26, 2016

Additional Identifiers

Package DI Number

14719872480034

Quantity per Package

6

Contains DI Package

04719872480037

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"HEALTH & LIFE 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. 37