Omron Blood Pressure Monitor - Digital Upper Arm Blood Pressure Monitor with 9" - Omron Healthcare, Inc.

Duns Number:054318779

Device Description: Digital Upper Arm Blood Pressure Monitor with 9" to 17" Easy-Wrap Cuff

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More Product Details

Catalog Number

BP769CAN

Brand Name

Omron Blood Pressure Monitor

Version/Model Number

BP769CAN

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

K133383,K133383

Product Code Details

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

00910eca-e06c-4710-80d1-5af4a575b1d0

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

September 01, 2017

Additional Identifiers

Package DI Number

20073796769318

Quantity per Package

6

Contains DI Package

00073796769314

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"OMRON HEALTHCARE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 48