Catalog Number

HS-XL

Brand Name

PadPro

Version/Model Number

HS-XL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 06, 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"

-

For Single-Use

-

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

K003548

Product Code

MKJ

Product Code Name

Automated external defibrillators (non-wearable)

Public Device Record Key

a2cd28ae-61d1-43b1-91d9-5d74437efffe

Public Version Date

June 07, 2022

Public Version Number

4

DI Record Publish Date

October 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-