HeartStart - PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

Duns Number:079503890

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More Product Details

Catalog Number

989803210531

Brand Name

HeartStart

Version/Model Number

989803210531

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

LDD

Product Code Name

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

Device Record Status

Public Device Record Key

b47a4778-a6a8-4686-b3cf-b202bf520e19

Public Version Date

November 08, 2021

Public Version Number

1

DI Record Publish Date

October 29, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PHILIPS ELECTRONICS NORTH AMERICA CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 14
3 A medical device with high risk that requires premarket approval 53