AccessGUDID - DEVICE: HeartSine Samaritan PAD 350P (05060167128042)

GUDID

Device Identifier (DI) Information

Brand Name: HeartSine Samaritan PAD 350P
Version or Model: SAM 350P
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 350-STR-US-GW
Company Name: HEARTSINE TECHNOLOGIES LTD

Primary DI Number: 05060167128042
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):	No
Over the Counter (OTC):	Yes
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?
47910	Non-rechargeable public semi-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 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.	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: 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: 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: 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.
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 57.2 and 106 KiloPascal
Handling Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 0 and 50 Degrees Celsius
Storage Environment Temperature: between 0 and 50 Degrees Celsius
Handling 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: ffaa0bfe-6ef4-4822-9e39-3eb7ac745a6f
Public Version Date: March 03, 2023
Public Version Number: 2
DI Record Publish Date: October 23, 2020