Catalog Number

-

Brand Name

LotFancy

Version/Model Number

11A-1809-O

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

9378f610-8940-4a7f-8355-9568cc2cbca3

Public Version Date

April 29, 2020

Public Version Number

5

DI Record Publish Date

November 30, 2016

Package DI Number

16939663924945

Quantity per Package

27

Contains DI Package

06939663924948

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-