FDA UDI
In Commercial Distribution
🇺🇸 United States
PM-720
DI: 00185098000320
·
Model: PM-720
·
PRO MEDICAL SUPPLIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PM-720
- Primary DI
- 00185098000320
- Version / Model
- PM-720
- Catalog Number
- PM-720
- Company Name
- PRO MEDICAL SUPPLIES, INC.
- Labeler DUNS
- 135741127
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-24
- Public Version
- 3
- Public Version Date
- 2021-02-19
- Public Version Status
- Update
- Public Device Record Key
- 4cc26456-5c3f-44ae-ae38-a47a64421f43
Device Description
(1) - Transcutaneous Nerve Stimulator/Electrical Muscle Stimulator Combination with Timer -Ten Mode Dual Channel 4 Leads - Zipper Case Includes: device, lead wires, 9V battery and (1) pack of electrodes, dual language instruction manual
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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | Physical Medicine | 890.5850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35995 | Transcutaneous electrical stimulation electrode, single-use | An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00185098000320 | GS1 |
Customer Contacts
- Phone
- 215-938-0200
- [email protected]