Publix - Wrist BPM - Digital Wrist Blood Pressure Monitor - PUBLIX SUPER MARKETS, INC.

Duns Number:006922009

Device Description: Digital Wrist Blood Pressure Monitor

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More Product Details

Catalog Number

UB-521P

Brand Name

Publix - Wrist BPM

Version/Model Number

UB-521P

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

-

Product Code Details

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

7820684a-95b0-497a-b1e5-3203bbe767af

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

June 15, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PUBLIX SUPER MARKETS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 17