FDA UDI
In Commercial Distribution
🇺🇸 United States
IOPI®
DI: 10810091040055
·
Model: Report Generator v 1.0
·
Iopi Medical LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- IOPI®
- Primary DI
- 10810091040055
- Version / Model
- Report Generator v 1.0
- Catalog Number
- 5-8101
- Company Name
- Iopi Medical LLC
- Labeler DUNS
- 828391396
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-20
- Public Version
- 3
- Public Version Date
- 2025-07-30
- Public Version Status
- Update
- Public Device Record Key
- d3e433fd-7db0-4a7d-9768-734a4c7fb130
Device Description
IOPI® Report Generator software is an accessory approved for use with the IOPI® Model 3.1 (Pro) and/or the Model 3.2 (Trainer), which are medical devices that measure, evaluate, and increase the strength and endurance of the tongue and lip in patients with oral motor disorders, including dysphagia, dysarthria, and obstructive sleep apnea. This software provides healthcare professionals with a report of device usage to allow them to document and analyze patient progress and usage. This software is intended for clinical use only.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| IKE | Transducer, Miniature Pressure | Physical Medicine | 890.1615 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63454 | Dynamometer force gauge | An electrically-powered component of a digital (electric) dynamometer intended to measure and display and/or communicate forces during assessment of neuromuscular function. It is a small unit with a built-in force sensor and is intended to be used with an appropriate dynamometer attachment(s); it is not a complete dynamometer. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810091040062 | GS1 | Bag (EN) | 1 | Not in Commercial Distribution | 2025-07-01 |
| Primary | 10810091040055 | GS1 | ||||
| Package | 10810091040185 | GS1 | Bag (ES) | 1 | Not in Commercial Distribution | 2025-07-01 |
Customer Contacts
- Phone
- 425-549-0139
- [email protected]