FDA.reportPublic FDA data

HeartSine Samaritan PAD 350P

Primary DI
05060167120855
Brand
HeartSine Samaritan PAD 350P
Company
HEARTSINE TECHNOLOGIES LTD
Model
SAM 350P
Catalog number
350-STR-AS-AV
Device description
Automated External Defibrillator
Published
2020-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
P160008004
P160008009

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P160008004HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P)Heartsine Technologies, Ltd.2017-01-12MKJ
P160008009HeartSine 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
05060167120855PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060167120855050601671208555060167120855

GMDN Terms#

Term, Definition table
TermDefinition
Non-rechargeable public semi-automated external defibrillatorA portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it audibly/visually instructs an operator to enable it to activate defibrillation of the heart through application of electrical shocks to the chest surface. It is placed in conspicuous public locations and is intended to be operated by a layperson. It consists of two skin-adhesive, cartridge-type, disposable electrodes containing non-rechargeable batteries that provide the shock energy, and an electrode-regulating external pulse generator (EPG), which may include a CPR feedback.

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, Specify00If device with Pad-Pak or Pediatric-Pak has been transported in temperatures below 0C (32F), return to an ambient temperature between 32F to 122F (0C to 50C) for at least 24 hours before use.
Special Storage Condition, Specify00Ingress Protection IP56 rating against dust and water spray. Rating does not cover the immersion of device in water or fluid. Contact with fluids may damage the device or cause fire or shock hazard.
Special Storage Condition, Specify00Ingress ProtectionIP56 rating against dust and water spray. Rating does not cover the immersion of device in water or fluid. Contact with fluids may damage the device or cause fire or shock hazard.
Special Storage Condition, Specify00Susceptibility to Electromagnetic interference Portable RF communications equipment (including antenna cables and external antennas) should not be used closer than 30 cm to any part of the device.
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

Regulatory Flags#

DUNS number
230479318
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00810149098208R&D Batteries, Inc.R & D Batteries, Inc.MKJ2025-11-19
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20192253017608Medi-Trace CadenceCardinal Health 200, LLCMKJ2024-02-28
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10884838002866HeartStartPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2022-01-06
10884838022048Adult/Child Pre-Connect Defib PadPHILIPS ELECTRONICS NORTH AMERICA CORPORATIONMKJ2022-01-06
20192253017554Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-08-19
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20192253018889Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-29
20192253017547Medi-Trace CadenceCardinal Health 200, LLCMKJ2021-07-28
20192253017295KendallCardinal Health 200, LLCMKJ2021-05-06
20192253017455KendallCardinal Health 200, LLCMKJ2021-05-05
20192253017721KendallCardinal Health 200, LLCMKJ2021-05-05
20192253017745KendallCardinal Health 200, LLCMKJ2021-05-05