FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00840682103633
·
Model: NMT Electrodes, Solid Gel, Ag-AgCl
·
GE Healthcare Finland Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00840682103633
- Version / Model
- NMT Electrodes, Solid Gel, Ag-AgCl
- Company Name
- GE Healthcare Finland Oy
- Labeler DUNS
- 401966697
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-17
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 3d017ef7-ebb6-4948-877a-aeea7f248ea7
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
- No
- MRI Safety
- MR Unsafe
- 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 |
|---|---|---|---|---|
| KOI | STIMULATOR, NERVE, PERIPHERAL, ELECTRIC | Anesthesiology | 868.2775 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59689 | Neuromuscular transmission electrode | A non-sterile electrical conductor designed to be applied to a patient's body surface, typically the forearm or ankle, to deliver stimulating electrical pulses to a motor nerve or measure electrical impulses from the nerve during neuromuscular transmission (NMT) monitoring. It is typically a disk-like electrode that is affixed to the skin with a special adhesive and a conductive gel (pre-gelled) intended to be used for neuromuscular block monitoring and nerve stimulation for brachial plexus anaesthesia. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840682103633 | GS1 |
Customer Contacts
- Phone
- +1(800)558-5120
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051635 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 12 – 30 Degrees Celsius