AccessGUDID - DEVICE: HeartSine Samaritan PAD 360P (05060167120909)

GUDID

Device Identifier (DI) Information

Brand Name: HeartSine Samaritan PAD 360P
Version or Model: SAM 360P
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 360-STR-AS-10
Company Name: HEARTSINE TECHNOLOGIES LTD

Primary DI Number: 05060167120909
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 230479318 *Terms of Use

Device Description: Automated External Defibrillator

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
48047	Non-rechargeable public automated external defibrillator	A portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it automatically activates defibrillation of the heart through application of electrical shocks to the chest surface. The device is placed in conspicuous public locations and is intended to be applied to the patient by a layperson. It consists of an external pulse generator (EPG) with a cardiac rhythm recognition system and a pair of skin-adhesive electrodes to monitor the rhythm and deliver the shocks; it also includes a non-rechargeable battery for energy.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MKJ	Automated external defibrillators (non-wearable)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160008	004
P160008	009

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Susceptibility 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.
Special Storage Condition, Specify: If 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, Specify: Ingress 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.
Handling Environment Atmospheric Pressure: between 57.2 and 106 KiloPascal
Handling Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 50 Degrees Celsius
Handling Environment Temperature: between 0 and 50 Degrees Celsius
Storage Environment Atmospheric Pressure: between 57.2 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ba953f16-2eab-4cd9-b93b-b38d6698c9a9
Public Version Date: November 02, 2020
Public Version Number: 1
DI Record Publish Date: October 23, 2020