Pediatric-Pak - Battery and Electrode Cartridge - HEARTSINE TECHNOLOGIES LTD

Duns Number:230479318

Device Description: Battery and Electrode Cartridge

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More Product Details

Catalog Number

PAD-PAK-02

Brand Name

Pediatric-Pak

Version/Model Number

Pad-Pak-02

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"

Yes

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

P160008,P160008

Product Code Details

Product Code

MKJ

Product Code Name

Automated external defibrillators (non-wearable)

Device Record Status

Public Device Record Key

e06bc86c-25d8-4fb0-8728-b9e3bafaaa52

Public Version Date

August 28, 2020

Public Version Number

1

DI Record Publish Date

August 20, 2020

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