Catalog Number

-

Brand Name

Lightning Products

Version/Model Number

01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2019

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

K081951

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

a6aaa04a-7450-4f98-b4ea-86a735add697

Public Version Date

December 31, 2019

Public Version Number

6

DI Record Publish Date

August 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-