Catalog Number

MDSPEDPHY

Brand Name

Medline

Version/Model Number

MDSPEDPHY

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K081442,K081442

Product Code

LDD

Product Code Name

Dc-defibrillator, low-energy, (including paddles)

Public Device Record Key

717eace5-b5fe-4f6e-bab5-588386291b84

Public Version Date

September 24, 2021

Public Version Number

1

DI Record Publish Date

September 16, 2021

Package DI Number

20888277634944

Quantity per Package

10

Contains DI Package

10888277634947

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE