FDA UDI
In Commercial Distribution
🇺🇸 United States
WiTOF
DI: 03665023000566
·
Model: WiTOF
·
IDMED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- WiTOF
- Primary DI
- 03665023000566
- Version / Model
- WiTOF
- Company Name
- IDMED
- Labeler DUNS
- 260233256
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-19
- Public Version
- 1
- Public Version Date
- 2025-12-29
- Public Version Status
- New
- Public Device Record Key
- 4ccbcbe9-c56d-43a1-b4ca-5d9bfb0f0105
Device Description
WiTOF complete kit (WiTOF-MU, power supply, clamp, hand sensor (WiTOF-S), user manual)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 59693 | Neuromuscular transmission lead set | A device(s) intended exclusively to conduct electrical neuromuscular transmission (NMT) signals to/from an array of neuromuscular electrodes attached to the surface of the skin of the hand and forearm, or the foot. The signals are subsequently conducted via a cable to a patient monitoring module to assess the degree of neuromuscular block in a patient. The patient-contact electrodes are not included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03665023000566 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243339 | 000 |