FDA UDI
In Commercial Distribution
🇺🇸 United States
HeartSine Samaritan PAD 360P
DI: 05060167120909
·
Model: SAM 360P
·
HEARTSINE TECHNOLOGIES LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HeartSine Samaritan PAD 360P
- Primary DI
- 05060167120909
- Version / Model
- SAM 360P
- Catalog Number
- 360-STR-AS-10
- Company Name
- HEARTSINE TECHNOLOGIES LTD
- Labeler DUNS
- 230479318
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-23
- Public Version
- 1
- Public Version Date
- 2020-11-02
- Public Version Status
- New
- Public Device Record Key
- ba953f16-2eab-4cd9-b93b-b38d6698c9a9
Device Description
Automated External Defibrillator
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MKJ | Automated external defibrillators (non-wearable) | Cardiovascular | 870.5310 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060167120909 | GS1 |
Customer Contacts
- Phone
- +1(215)860-8100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P160008 | 004 |
| P160008 | 009 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- 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.
- Type
- Special Storage Condition, Specify
- Special Conditions
- 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.
- Type
- Special Storage Condition, Specify
- Special Conditions
- 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.
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 57.2 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 57.2 – 106 KiloPascal