Identity
- Trade Name
- EarDome FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- EarDomes (2 pack) for use with Vivosonic Screener (DI: 00627908020017). The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10) FDA UDI
- Model / Reference
- 100004 FDA UDI
- Description
- EarDomes (2 pack) for use with Vivosonic Screener (DI: 00627908020017). The UDI is comprised of the following: GTIN (01) + EXPIRY (17) + BATCH/LOT (10) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627908070074 FDA UDI
- 510(k) Number
- K043396 FDA UDI
- FDA Product Code
- GWJ FDA UDI
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Evoked-potential audiometer
EarDome by Vivosonic Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Evoked-potential audiometer.
- Ear Tip PM014H Pack/100 pcs. — PATH medical GmbH · Class II
- Ear Tip ET-12 Pack/100 pcs. — PATH medical GmbH · Class II
- Insert Earphone PIEP monaural — PATH medical GmbH · Class II
- QScreen Set — PATH medical GmbH · Class II
- Ear Tip ET-S11 Pack/100 pcs. — PATH medical GmbH · Class II
- TE Tip Sample Box — Otodynamics · Class II
- Tip Sample Box (Neonate) — Otodynamics · Class II
- Otoport LCD service kit — Otodynamics · Class II
Cleared under the same submission
K043396 also covers:
- Bone Conductor — Vivosonic Inc
- ECochG Adapters — Vivosonic Inc
- EP Headphones — Vivosonic Inc
- Integrity Amplitrode — Vivosonic Inc
- Integrity Amplitrode — Vivosonic Inc
- Integrity Amplitrode — Vivosonic Inc
- Integrity Bone Conductor — Vivosonic Inc
- Integrity Bone Conductor — Vivosonic Inc
- Integrity CV-Amp — Vivosonic Inc
- Integrity Computer — Vivosonic Inc
- Integrity EP Headphones — Vivosonic Inc
- Integrity EP Headphones — Vivosonic Inc
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Vivosonic Inc
Sources (1)
- FDA UDI 81ec1f11-d8c1-4733-960d-197c5e9ca52d 34 fields · synced May 30, 2026