AfibAlert - The AfibAlert® is a cardiac event recorder - LOHMAN TECHNOLOGIES, LLC

Duns Number:080381900

Device Description: The AfibAlert® is a cardiac event recorder capable of recording and storing ~five hundred

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

790.0102.001

Brand Name

AfibAlert

Version/Model Number

V1.5

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 16, 2022

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

K052767,K052767,K052767

Product Code Details

Product Code

DXH

Product Code Name

Transmitters And Receivers, Electrocardiograph, Telephone

Device Record Status

Public Device Record Key

69645e0e-0475-4100-af88-6b43f04b4866

Public Version Date

October 17, 2022

Public Version Number

4

DI Record Publish Date

July 01, 2020

Additional Identifiers

Package DI Number

00860003939710

Quantity per Package

10

Contains DI Package

00860003939703

Package Discontinue Date

October 16, 2022

Package Status

Not in Commercial Distribution

Package Type

Box

"LOHMAN TECHNOLOGIES, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1