Catalog Number

-

Brand Name

LotFancy

Version/Model Number

11C-1823-C

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

cd84bca7-c008-4242-8f9a-5ca9ec7e1292

Public Version Date

April 29, 2020

Public Version Number

5

DI Record Publish Date

November 16, 2016

Package DI Number

16939663925041

Quantity per Package

27

Contains DI Package

06939663925044

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-