Pad-Pak - Combined Battery and Electrode Cartridge. - HEARTSINE TECHNOLOGIES LTD

Duns Number:230479318

Device Description: Combined Battery and Electrode Cartridge. Accessory to a therapeutic medical device in th Combined Battery and Electrode Cartridge. Accessory to a therapeutic medical device in the range of Automated External Defibrillators.

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More Product Details

Catalog Number

Pad-Pak-01

Brand Name

Pad-Pak

Version/Model Number

Pad-Pak-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

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

MKJ

Product Code Name

Automated External Defibrillators (Non-Wearable)

Device Record Status

Public Device Record Key

4fdf9e7b-3182-43f8-9940-a5e6a40b3670

Public Version Date

March 29, 2018

Public Version Number

2

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

-

"HEARTSINE TECHNOLOGIES LTD" Characteristics
Device Class Device Class Description No of Devices
3 A medical device with high risk that requires premarket approval 28