FDA UDI
In Commercial Distribution
🇺🇸 United States
FR2/FR2+ Adult Electrode Pads
DI: 00884838023710
·
Model: DP Electrode Pads
·
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FR2/FR2+ Adult Electrode Pads
- Primary DI
- 00884838023710
- Version / Model
- DP Electrode Pads
- Catalog Number
- 989803158211
- Company Name
- PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
- Labeler DUNS
- 079503890
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 6
- Public Version Date
- 2023-02-09
- Public Version Status
- Update
- Public Device Record Key
- 855637c0-c7f4-4628-ab89-27cdb0384a75
Device Description
1-pack HS FR/FR2 Defib Pads (DP2/DP6)
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 45806 | Multifunction cardiac electrode, adult | A non-sterile electrical conductor designed to be applied to an adult patient for automatic or manual defibrillation, external pacing, cardioversion, and electrocardiographic monitoring through transmission of cardiac bioelectric signals (typically from the thoracic surface) to devices that record/process the signals and potentially return electrical impulses [e.g., electrocardiograph, electrocardiographic monitor(s), defibrillator]. It is a disk-like electrode that is affixed to the skin with a special adhesive and a conductive gel (pre-gelled). It may be made of x-ray translucent materials and may include permanently attached lead wires. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00884838023710 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 122 Degrees Fahrenheit