MESI ABPI MD - The MESI ABPI MD is an automated wireless - MESI d.o.o.

Duns Number:500719478

Device Description: The MESI ABPI MD is an automated wireless ankle-brachial index measuring device for scre The MESI ABPI MD is an automated wireless ankle-brachial index measuring device for screening patients for Peripheral Arterial Disease (PAD/LEAD). The device is intended to perform, view and store ankle-brachial index (ABI) measurements of adult patients –patients in the PAD risk group.

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More Product Details

Catalog Number

301-000080

Brand Name

MESI ABPI MD

Version/Model Number

ABPIMDD

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K172655

Product Code Details

Product Code

JOM

Product Code Name

Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

Device Record Status

Public Device Record Key

30b5c7f7-c25c-4783-8bb5-ed5be5cc405e

Public Version Date

July 19, 2021

Public Version Number

1

DI Record Publish Date

July 09, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MESI D.O.O." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3