FDA UDI
In Commercial Distribution
🇺🇸 United States
TwitchView™
DI: 00860298001055
·
Model: Electrode v1
·
BLINK DEVICE COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- TwitchView™
- Primary DI
- 00860298001055
- Version / Model
- Electrode v1
- Company Name
- BLINK DEVICE COMPANY
- Labeler DUNS
- 105714027
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-05
- Public Version
- 1
- Public Version Date
- 2018-10-08
- Public Version Status
- New
- Public Device Record Key
- 18634b3f-962b-4495-a511-f5735dd1e606
Device Description
Supporting infection control, TwitchView™ utilizes a single-patient use Electrode Array. With the flexibility to secure to either left or right hand in seconds, the Electrode Array is easily adopted into the pre-surgical workflow. The one-piece, auto-centering design mitigates placement errors—a common cause of intra-operative system failure and measurement inaccuracies.
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 00860298001086 | GS1 | Box | 25 | In Commercial Distribution | |
| Primary | 00860298001055 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172843 | 000 |