Catalog Number

-

Brand Name

LotFancy

Version/Model Number

11C-1876-D

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

K092245,K092245

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

a1f8f284-71ca-48c6-8083-b650203237ad

Public Version Date

May 15, 2020

Public Version Number

4

DI Record Publish Date

February 16, 2017

Package DI Number

16970384253204

Quantity per Package

24

Contains DI Package

06970384253207

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-