FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PHILIPS HeartStart OnSite
DI: 00884838050693
·
Model: 861337
·
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PHILIPS HeartStart OnSite
- Primary DI
- 00884838050693
- Version / Model
- 861337
- Catalog Number
- 861337
- Company Name
- PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
- Labeler DUNS
- 079503890
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 6
- Public Version Date
- 2023-04-28
- Public Version Status
- Update
- Public Device Record Key
- 97b60979-8740-45c9-b06e-3d7cfa0cbed1
- Distribution End Date
- 2016-06-10
Device Description
Guidelines Update, Home
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| NSA | Over-The-Counter Automated External Defibrillator | Cardiovascular | 870.5310 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48050 | Home automated external defibrillator | A portable electronic device available for use by a patient/layperson outside a clinical setting 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 consists of an external pulse generator (EPG), skin-adhesive electrodes that monitor the rhythm/deliver the shocks, and a non-rechargeable battery for energy that requires replacement when indicated by the EPG. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838050693 | GS1 |