PHILIPS FR/FR2/FR2+ Adult Electrode Pads - 5-pack HS FR/FR2 Defib Pads (DP2/DP6) - PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

Duns Number:079503890

Device Description: 5-pack HS FR/FR2 Defib Pads (DP2/DP6)

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

989803158221

Brand Name

PHILIPS FR/FR2/FR2+ Adult Electrode Pads

Version/Model Number

989803158221

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

Yes

Prescription Use (Rx)

-

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

MKJ

Product Code Name

Automated External Defibrillators (Non-Wearable)

Device Record Status

Public Device Record Key

4e326e91-e7b7-41c2-a4c7-54c62ddf878a

Public Version Date

May 03, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2014

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