FDA.reportPublic FDA data

Pad-Pak

Primary DI
M727PADPAK01
Brand
Pad-Pak
Company
HEARTSINE TECHNOLOGIES LTD
Model
Pad-Pak-01
Catalog number
Pad-Pak-01
Device description
Combined Battery and Electrode Cartridge. Accessory to a therapeutic medical device in the range of Automated External Defibrillators.
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MKJAutomated external defibrillators (non-wearable)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKJAutomated External Defibrillators (Non-Wearable)Cardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P160008008

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160008008HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)Heartsine Technologies, Ltd.2017-01-12MKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M727PADPAK01PreviousHIBCC0
05060167120466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060167120466050601671204665060167120466

GMDN Terms#

Term, Definition table
TermDefinition
Non-rechargeable public semi-automated external defibrillator electrode, adultAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure57.2 KiloPascal106 KiloPascal
Handling Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius50 Degrees Celsius
Storage Environment Atmospheric Pressure57.2 KiloPascal106 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(215)860-8100heartsinesupport@stryker.com
1-866-478-7463info@heartsine.com

Regulatory Flags#

DUNS number
230479318
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060167124488Pad-PakPad-Pak-07PAD-PAK-072020-08-20
05060167120466Pad-PakPad-Pak-01PAD-PAK-012020-08-20
05060167120473Pediatric-PakPad-Pak-02PAD-PAK-022020-08-20
M727PADPAK07Pad-PakPad-Pak-07Pad-Pak-072014-09-24
M727PADPAK02Pediatric-PakPad-Pak-02Pad-Pak-022014-09-24
05060167120701HeartSine Samaritan PAD 350PSAM 350P350-STR-US-AV2020-10-27
05060167120671HeartSine Samaritan PAD 350PSAM 350P350-STR-US-102020-10-23
05060167128042HeartSine Samaritan PAD 350PSAM 350P350-STR-US-GW2020-10-23
05060167120695HeartSine Samaritan PAD 450PSAM450P450-STR-US-102020-10-27
05060167120886HeartSine Samaritan PAD 450PSAM450P450-STR-AS-AV2020-10-27
05060167120893HeartSine Samaritan PAD 350PSAM 350P350-STR-AS-102020-10-27
05060167120916HeartSine Samaritan PAD 450PSAM450P450-STR-AS-102020-10-27
05060167128066HeartSine Samaritan PAD 360PSAM 360P360-STR-US-GW2020-10-27
05060167129711HeartSine Samaritan PAD 350PSAM350P350-STR-AS-GW2020-10-27
05060167129735HeartSine Samaritan PAD 360PSAM360P360-STR-AS-GW2020-10-27
05060167129773HeartSine Samaritan PAD 450PSAM450P450-STR-AS-GW2020-10-27
05060167120688HeartSine Samaritan PAD 360PSAM 360P360-STR-US-102020-10-23
05060167120718HeartSine Samaritan PAD 360PSAM360P360-STR-US-AV2020-10-23
05060167120725HeartSine Samaritan PAD 450PSAM450P450-STR-US-AV2020-10-23
05060167120855HeartSine Samaritan PAD 350PSAM 350P350-STR-AS-AV2020-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00815098021475Defibtech ARM XR Extended Suction Cup (package of 1)DEFIBTECH, L.L.C.MKJ2026-06-26
00812394027279RADIOTRANSPARENT DEFIBRILLATION ELECTRODEZoll Medical CorporationMKJ2026-05-29
10812394027276RADIOTRANSPARENT DEFIBRILLATION ELECTRODEZoll Medical CorporationMKJ2026-05-29
00883873031902LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873031933LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873031957LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873031971LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873031995LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873032015LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00883873032145LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2026-04-17
00197644380145AED Battery ExchangeAED BATTERY EXCHANGE, LLCMKJ2026-04-15
00810149098291R&D Batteries, Inc.R & D Batteries, Inc.MKJ2026-04-01
10847946001435PEDI PADZZoll Medical CorporationMKJ2026-02-12
10847946016231ONESTEPZoll Medical CorporationMKJ2026-02-12
10847946023345ONESTEPZoll Medical CorporationMKJ2026-02-12
07613327673197LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673227LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673234LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673241LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673258LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673265LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327673357LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
07613327681864LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2025-12-18
00810149098208R&D Batteries, Inc.R & D Batteries, Inc.MKJ2025-11-19
00883873760482BATTERY, LI-ION, WITH IFU, LP35PHYSIO-CONTROL, INC.MKJ2025-09-26
00883873761533LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2024-09-04
00883873761540LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2024-09-04
00883873761557LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2024-09-04
00883873761564LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2024-09-04
00883873761571LIFEPAK 35 Monitor/DefibrillatorPHYSIO-CONTROL, INC.MKJ2024-09-04