FDA UDI
Not in Commercial Distribution
🇺🇸 United States
VERMED
DI: 15060441915532
·
Model: F7958W
·
NISSHA MEDICAL TECHNOLOGIES LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- VERMED
- Primary DI
- 15060441915532
- Version / Model
- F7958W
- Catalog Number
- 4011056C
- Company Name
- NISSHA MEDICAL TECHNOLOGIES LTD
- Labeler DUNS
- 671405566
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-24
- Public Version
- 6
- Public Version Date
- 2023-02-20
- Public Version Status
- Update
- Public Device Record Key
- 819f1e5e-3431-4af6-820c-f87c3680a61b
- Distribution End Date
- 2022-05-18
Device Description
Disposable multifunctionelectrodes for defibrillation, synchronized cardioversion, transcutaneous cardiac stimulation and ECG monitoring, with direct connection to cables and 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 |
|---|---|---|---|---|
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | Cardiovascular | 870.5300 | 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 |
|---|---|---|---|---|---|---|
| Package | 35060441915536 | GS1 | BOX | 10 | Not in Commercial Distribution | 2022-05-18 |
| Primary | 15060441915532 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103783 | 000 |