Catalog Number

4011048C

Brand Name

VERMED

Version/Model Number

F7751

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 18, 2022

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K103783,K103783

Product Code

LDD

Product Code Name

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

Public Device Record Key

d5011f87-88fe-42fb-8626-09eedd98fa82

Public Version Date

May 19, 2022

Public Version Number

5

DI Record Publish Date

January 24, 2018

Package DI Number

35060441915468

Quantity per Package

10

Contains DI Package

15060441915464

Package Discontinue Date

May 18, 2022

Package Status

Not in Commercial Distribution

Package Type

BOX