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Pad-Pak

FDA UDI

Class III (US FDA UDI)

by Heartsine Technologies Ltd

Identity

Trade Name
Pad-Pak FDA UDI
Generic Name
Non-rechargeable public semi-automated external defibrillation electrode, adult FDA UDI
Device Name
Battery and Electrode Cartridge FDA UDI
Model / Reference
Pad-Pak-01 FDA UDI
Description
Battery and Electrode Cartridge FDA UDI

Identifiers

Catalog Number
PAD-PAK-01 FDA UDI
Primary DI / UDI-DI
05060167120466 FDA UDI
PMA Number
P160008 FDA UDI
FDA Product Code
MKJ FDA UDI
GMDN Term
Non-rechargeable public semi-automated external defibrillation electrode, adult FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
870.5310 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Non-rechargeable public semi-automated external defibrillation electrode, adult

Pad-Pak by Heartsine Technologies Ltd — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-rechargeable public semi-automated external defibrillation electrode, adult.

Cleared under the same submission

P160008 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Heartsine Technologies Ltd

Sources (1)

  • FDA UDI 66cad64d-d8b6-4bd5-a960-a8341ee20acd 37 fields · synced Jun 6, 2026