HeartSine Samaritan PAD 360P 360-STR-AS-10

GUDID 05060167120909

Automated External Defibrillator

HEARTSINE TECHNOLOGIES LTD

Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator Non-rechargeable public automated external defibrillator

• Primary Device ID: 05060167120909
• NIH Device Record Key: ba953f16-2eab-4cd9-b93b-b38d6698c9a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeartSine Samaritan PAD 360P
• Version Model Number: SAM 360P
• Catalog Number: 360-STR-AS-10
• Company DUNS: 230479318
• Company Name: HEARTSINE TECHNOLOGIES LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(215)860-8100
• Email: heartsinesupport@stryker.com
• Phone: +1(215)860-8100
• Email: heartsinesupport@stryker.com
• Phone: +1(215)860-8100
• Email: heartsinesupport@stryker.com
• Phone: +1(215)860-8100
• Email: heartsinesupport@stryker.com
• Phone: +1(215)860-8100
• Email: heartsinesupport@stryker.com
• Phone: +1(215)860-8100
• Email: heartsinesupport@stryker.com
• Phone: +1(215)860-8100
• Email: heartsinesupport@stryker.com
• Phone: +1(215)860-8100
• Email: heartsinesupport@stryker.com
• Phone: +1(215)860-8100
• Email: heartsinesupport@stryker.com
• Phone: +1(215)860-8100
• Email: heartsinesupport@stryker.com
• Phone: +1(215)860-8100
• Email: heartsinesupport@stryker.com
• Phone: +1(215)860-8100
• Email: heartsinesupport@stryker.com
• Phone: +1(215)860-8100
• Email: heartsinesupport@stryker.com
• Phone: +1(215)860-8100
• Email: heartsinesupport@stryker.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *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: Between 0 and 0 *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 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *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: Between 0 and 0 *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 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *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: Between 0 and 0 *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 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *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: Between 0 and 0 *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 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *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: Between 0 and 0 *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 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *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: Between 0 and 0 *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 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *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: Between 0 and 0 *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 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *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: Between 0 and 0 *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 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *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: Between 0 and 0 *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 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *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: Between 0 and 0 *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 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *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: Between 0 and 0 *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 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *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: Between 0 and 0 *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 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *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: Between 0 and 0 *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 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 106 KiloPascal
• Special Storage Condition, Specify: Between 0 and 0 *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: Between 0 and 0 *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: Between 0 and 0 *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 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57.2 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060167120909 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160008

FDA Product Code

• MKJ: Automated external defibrillators (non-wearable)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-02
• Device Publish Date: 2020-10-23

On-Brand Devices [HeartSine Samaritan PAD 360P]

• 05060167120909: Automated External Defibrillator
• 05060167120862: Automated External Defibrillator
• 05060167120718: Automated External Defibrillator
• 05060167120688: Automated External Defibrillator
• 05060167129735: Automated External Defibrillator
• 05060167128066: Automated External Defibrillator