FDA UDI
In Commercial Distribution
🇺🇸 United States
Otoport Pro Clinical+TE
DI: 05060396173264
·
Model: OPRO-CLN-DT
·
OTODYNAMICS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Otoport Pro Clinical+TE
- Primary DI
- 05060396173264
- Version / Model
- OPRO-CLN-DT
- Company Name
- OTODYNAMICS LIMITED
- Labeler DUNS
- 235908050
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-17
- Public Version
- 1
- Public Version Date
- 2024-07-25
- Public Version Status
- New
- Public Device Record Key
- d8ecfa94-c813-4ad0-97f6-4d6261a05292
Device Description
Handheld, portable, Otoacoustic Emission [OAE] analyser for Clinical OAE hearing test applications. Includes Otoport Pro instrument, ear probe, system items, and DPOAE+TEOAE Clinical licence
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
- 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 |
|---|---|---|---|---|
| EWO | Audiometer | Ear, Nose, Throat | 874.1050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58019 | Otoacoustic emission system, battery-powered | An assembly of battery-powered devices designed to record and analyse the faint sounds hair cells in the inner ear emit [otoacoustic emission (OAE)] in response to a stimulus (e.g., click, tone burst, pure-tone signals) to test for a deficiency of function in the ear during diagnostic evaluation and/or neonatal screening. It typically consists of a portable programmable unit, an OAE probe, and eartips. The stimulus signal is emitted via the probe inserted into the ear canal and the response is recorded via a microphone in the probe; OAEs are absent/reduced in patients with hearing loss. The system may be combined with other audiological devices (e.g., tympanometer, ABR device). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060396173264 | GS1 |
Customer Contacts
- Phone
- 1-800-659-7776
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240430 | 000 |