HeartStart

HS Switchless Int Pdl Adapter

Registry build 21.09.26
3manufacturers in China registered for this device type
9catalogue numbers in this listing

Who Else Makes It

All of them in Guangdong. 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LDD
Manufacturer City Province Registered as Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd. Dongguan Guangdong Contract manufacturer 77
Amphenol Alden Products Company Shenzhen Guangdong Contract manufacturer 24
EMI (Dongguan) Asia Limited Dongguan Guangdong Contract manufacturer 9

Record

Regulatory record for HeartStart
Listed by Philips Medical Systems Hsg
FDA product code LDD
Device type Dc-Defibrillator, Low-Energy, (Including Paddles)
Device class Class 2
Regulation 21 CFR 870.5300
Record published 2014-09-24
Record revised 2025-11-24 (version 10)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries lot or batch number, serial number
Storage Storage environment temperature -20 to 70 °C; Storage environment temperature -4 to 158 °F; Storage environment humidity 5 to 95 % RH
Distribution end date 2023-05-31

Catalogue Numbers

Catalogue numbers for HeartStart
Catalogue number Size Status
Small Switched Int Pdls In distribution
Small Switchless Int Pdl Withdrawn
Switched Int Pdl Adapter Withdrawn
Lrg Switched Int Pdls Withdrawn
Extra Lrg Switchless Internal Paddle Withdrawn
Medium Switched Int Pdls Withdrawn
Large Switchless Int Pdl Withdrawn
Extra Lrg Switched Int Pdls Withdrawn
Medium Switchless Int Pdl Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Unipower Unipower Corp. 623
Internal Handle Zoll Medical Corporation 89
Vermed Nissha Medical Technologies Limited 47
Cardio Clear Cardio Medical Products, Inc. 33
Dc-Defibrillator, Low-Energy, (Including Paddles) Fiab SPA 20
Dc-Defibrillator, Low-Energy, (Including Paddles) Physio-Control, Inc. 20
R2 ConMed Corporation 17
Anybattery Anybattery, Inc 6
Tempus LS-Manual Remote Diagnostic Technologies Ltd. 6
Vermed Defib Pads Graphic Controls Acquisition Corporation 5
HeartStart Philips Electronics North America Corporation 4
Heartsync by Vermed Graphic Controls Acquisition Corporation 4

Showing 12 of 29. All products under Dc-Defibrillator, Low-Energy, (Including Paddles)

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer