FDA.reportPublic FDA data

Pediatric-Pak

Primary DI
M727PADPAK02
Brand
Pediatric-Pak
Company
HEARTSINE TECHNOLOGIES LTD
Model
Pad-Pak-02
Catalog number
Pad-Pak-02
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
M727PADPAK02PreviousHIBCC0
05060167120473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060167120473050601671204735060167120473

GMDN Terms#

Term, Definition table
TermDefinition
Non-rechargeable public semi-automated external defibrillator electrode, paediatricAn 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 a pre-pubescent 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
Special Storage Condition, Specify00DO NOT STORE the Pediatric-Pak next to magnetically sensitive storage media as it contains a magnetic component (surface strength 6500 gauss).
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
M727PADPAK01Pad-PakPad-Pak-01Pad-Pak-012014-09-24
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