GARMIN - INDEX™ tubeless blood pressure monitor. - YA HORNG ELECTRONIC CO., LTD.

Duns Number:656103819

Device Description: INDEX™ tubeless blood pressure monitor.

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More Product Details

Catalog Number

-

Brand Name

GARMIN

Version/Model Number

BP707

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 20, 2022

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

-

Product Code Details

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

897803cd-6660-43c5-92aa-12f0121c6a63

Public Version Date

September 28, 2022

Public Version Number

1

DI Record Publish Date

September 20, 2022

Additional Identifiers

Package DI Number

14719873310071

Quantity per Package

12

Contains DI Package

04719873310074

Package Discontinue Date

September 20, 2022

Package Status

Not in Commercial Distribution

Package Type

-

"YA HORNG ELECTRONIC CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4