FDA UDI
In Commercial Distribution
🇺🇸 United States
IOPI®
DI: 10810091040239
·
Model: Model 3.1
·
Iopi Medical LLC
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- IOPI®
- Primary DI
- 10810091040239
- Version / Model
- Model 3.1
- Catalog Number
- 8-3101
- Company Name
- Iopi Medical LLC
- Labeler DUNS
- 828391396
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-21
- Public Version
- 1
- Public Version Date
- 2025-03-31
- Public Version Status
- New
- Public Device Record Key
- 2e25e926-2aa9-4efd-9379-f84e755ae424
Device Description
The IOPI® Pro (Model 3.1) is used by healthcare professionals to 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. The IOPI® Pro is intended for clinical use by healthcare professionals.
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
- 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 |
|---|---|---|---|---|
| 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 | 10810091040253 | GS1 | 1-3100-SD_EN | 1 | In Commercial Distribution | |
| Primary | 10810091040239 | GS1 | ||||
| Package | 10810091040321 | GS1 | 1-3100-SD_ES | 1 | In Commercial Distribution | |
| Package | 10810091040260 | GS1 | 1-3100-DL_EN | 1 | In Commercial Distribution | |
| Package | 10810091040420 | GS1 | 1-3100-DL_ES | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 425-549-0139
- [email protected]
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 93 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 65 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 15 – 93 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius