iBloodPressure Cellular Blood Pressure Monitor, Adult, Large - iBloodPressure Cellular Blood Pressure Monitor, - SMART METER LLC

Duns Number:117014140

Device Description: iBloodPressure Cellular Blood Pressure Monitor, Adult, Large

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More Product Details

Catalog Number

-

Brand Name

iBloodPressure Cellular Blood Pressure Monitor, Adult, Large

Version/Model Number

SMBP802-GS-003

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)

Yes

Over the Counter (OTC)

-

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

765dd15f-e48c-4a4e-9876-7d17023a1bb7

Public Version Date

November 25, 2021

Public Version Number

1

DI Record Publish Date

November 17, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SMART METER LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4