FDA.reportPublic FDA data

samaritan PAD

Primary DI
M727SAM350P
Brand
samaritan PAD
Company
HEARTSINE TECHNOLOGIES LTD
Model
SAM 350P
Device description
Semi-Automatic External Defibrillator
Published
2017-02-13
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M727SAM350PPrimaryHIBCC0

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
Special Storage Condition, Specify00Minus 10 to 50 degrees Celsius for up to two days. It should be returned to an ambient temperature of between 0 to 50 degrees Celsius for at least 24 hours before use.
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-866-478-7463info@heartsine.com

Regulatory Flags#

DUNS number
230479318
Device count
1
Serial number
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

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Primary DI, Brand, Company table
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