Meijer - Meijer Automatic Digital BP Unit - MEIJER, INC.

Duns Number:006959555

Device Description: Meijer Automatic Digital BP Unit

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More Product Details

Catalog Number

74-5021

Brand Name

Meijer

Version/Model Number

74-5021

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

b27c7a14-02ec-4130-8717-6c8fa60ab3cf

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

30760236653364

Quantity per Package

2

Contains DI Package

00760236653363

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Intermediate

"MEIJER, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 37
2 A medical device with a moderate to high risk that requires special controls. 45
U Unclassified 1