Catalog Number

-

Brand Name

Unipower

Version/Model Number

B11988

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K940842

Product Code

LDD

Product Code Name

Dc-Defibrillator, Low-Energy, (Including Paddles)

Public Device Record Key

fc5d1d2e-75f3-42ff-b8c3-9790b19d8868

Public Version Date

October 09, 2020

Public Version Number

1

DI Record Publish Date

October 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-