Pacific West Medical
Basic Information
- Brand Name
- Pacific West Medical
- Primary DI
- 00852397008028
- Version / Model
- PWMC100-Philips
- Catalog Number
- PWMC100-Philips
- Company Name
- PACIFIC WEST MEDICAL, INC.
- Labeler DUNS
- 926938275
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-03
- Public Version
- 3
- Public Version Date
- 2023-02-20
- Public Version Status
- Update
- Public Device Record Key
- 27ce71b8-9298-4c86-8770-b597b2d8ba8c
Device Description
The Pacific West Medical Adult/Child Radiotransparent Multi-Function Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on Adult/Child patients (>22lbs/10kg). When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 joule maximum). Compatible with Philips Plug style connector models of monophasic and bi-phasic defibrillators.
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 |
|---|---|---|---|---|
| MLN | Electrode, Electrodcardiograph, Multi-Function | Cardiovascular | 870.2360 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11130 | Electrode conductive skin pad, single-use | A noninvasive conductive material designed to facilitate electrical conduction between an external electrode (e.g., paddle-type defibrillator electrode) and the skin surface. It is available in various forms such as a thickened gel or polymer medium reinforced by a non-woven material, an adhesive pad/patch, or an absorbent material (e.g., felt) intended to be soaked in a conduction fluid. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852397008028 | GS1 | ||||
| Package | 00852397008059 | GS1 | Case | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- (800)705-3256
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K080421 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -4 – 104 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 40 Degrees Celsius