FDA UDI
In Commercial Distribution
🇺🇸 United States
Integrity V500
DI: 00627908010018
·
Model: V500
·
Vivosonic Inc
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Integrity V500
- Primary DI
- 00627908010018
- Version / Model
- V500
- Company Name
- Vivosonic Inc
- Labeler DUNS
- 201740425
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2020-04-21
- Public Version Status
- Update
- Public Device Record Key
- 1b19458a-cd17-40aa-a8ff-2ef6d6491785
Device Description
Main handheld VivoLink unit for use with the first generation Integrity V500 system. The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL) The following are accessories that can be used with the first generation Integrity V500 system: A61 Amplitrode: DI 00627908010025 B71-10 Bone Conductor: DI 00627908010032 ER-3A-ABR Insert Earphones: DI 00627908010049 HDA 300 EP Headphones: DI 00627908010056 P40-GP OAE Probe: DI 00627908010063 P40-UG OAE Probe: DI 00627908010070
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 |
| GWJ | Stimulator, Auditory, Evoked Response | Neurology | 882.1900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35747 | Evoked-potential audiometer | An electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage. | No | Active |
| 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 | 00627908010018 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K043396 | 000 |