Pad-Pak

Basic Information

• Brand Name: Pad-Pak
• Primary DI: 05060167124488
• Version / Model: Pad-Pak-07
• Catalog Number: PAD-PAK-07
• Company Name: HEARTSINE TECHNOLOGIES LTD
• Labeler DUNS: 230479318
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-20
• Public Version: 2
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 8a50d974-3a6e-48f3-83f6-ff20f7d11985

Device Description

Battery and Electrode Cartridge

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MKJ	Automated external defibrillators (non-wearable)	Cardiovascular	870.5310	3

GMDN Terms

Code	Name	Definition	Implantable	Status
47911	Non-rechargeable public semi-automated external defibrillation electrode, adult	An electrical conductor, with integral batteries and regulated by a dedicated external pulse generator (EPG), designed to create an electrical shock(s) and defibrillate the heart (restore normal rhythm) to treat ventricular fibrillation or pulseless ventricular tachycardia in an adult patient. It is a cartridge-type electrode, in pairs, with non-rechargeable batteries that provide the energy to produce the electrical shock(s) after its adhesive pads are placed on the skin of the patient. This is a single-use device that is replaced after a patient application or after elapse of its expiry date.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060167124488	GS1
Previous	M727PADPAK07	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P160008	008
P160008	009

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 57.2 – 106 KiloPascal
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 57.2 – 106 KiloPascal