Catalog Number

SM5000-IBAL

Brand Name

iBloodPressure

Version/Model Number

LS802-GS

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 29, 2020

Issuing Agency

In GS1

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

K123780,K123780

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

00409305-d718-4486-aad6-ff66f1a4700c

Public Version Date

September 30, 2020

Public Version Number

2

DI Record Publish Date

September 14, 2020

Package DI Number

10869876000036

Quantity per Package

10

Contains DI Package

00869876000039

Package Discontinue Date

September 29, 2020

Package Status

Not in Commercial Distribution

Package Type

Case