Catalog Number

350-STR-AS-10

Brand Name

HeartSine Samaritan PAD 350P

Version/Model Number

SAM 350P

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"

Yes

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

P160008,P160008

Product Code

MKJ

Product Code Name

Automated external defibrillators (non-wearable)

Public Device Record Key

2aeec190-f51d-4c94-9d42-e11168d9eeda

Public Version Date

November 04, 2020

Public Version Number

1

DI Record Publish Date

October 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-