FDA UDI
In Commercial Distribution
🇺🇸 United States
HeartSine Samaritan PAD 350P
DI: 05060167120893
·
Model: SAM 350P
·
HEARTSINE TECHNOLOGIES LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HeartSine Samaritan PAD 350P
- Primary DI
- 05060167120893
- Version / Model
- SAM 350P
- Catalog Number
- 350-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
- 2020-10-27
- Public Version
- 1
- Public Version Date
- 2020-11-04
- Public Version Status
- New
- Public Device Record Key
- 2aeec190-f51d-4c94-9d42-e11168d9eeda
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 |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060167120893 | 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
- Handling Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius
- 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
- Storage Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 57.2 – 106 KiloPascal
- 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
- Storage 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