Identity
- Trade Name
- Natus FDA UDI
- Generic Name
- Audiometric ear tip FDA UDI
- Device Name
- Infant Ear Tip, Blue, Size 4 mm, Qty 50 FDA UDI
- Model / Reference
- Infant Ear Tip 4 mm FDA UDI
- Description
- Infant Ear Tip, Blue, Size 4 mm, Qty 50 FDA UDI
Identifiers
- Catalog Number
- 1908-US FDA UDI
- Primary DI / UDI-DI
- 00382830054188 FDA UDI
- 510(k) Number
- K013977 FDA UDI
- FDA Product Code
- GWJ FDA UDI
- GMDN Term
- Audiometric ear tip 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 2.3 Millimeter FDA UDIHeight — 8.5 Millimeter FDA UDI
Category: Audiometric ear tip
Natus by Natus Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Audiometric ear tip.
- Amplivox — Interacoustics A/S · Class I
- Sanibel Supply — Interacoustics A/S · Class I
- Sanibel Supply — Interacoustics A/S · Class I
- Etymotic — ETYMOTIC RESEARCH, INC. · Class I
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Amplivox — Interacoustics A/S · Class I
- EarHug Pack - No Electrodes — Intelligent Hearing Systems Corp. · Class II
- Sanibel Supply — Interacoustics A/S · Class I
Cleared under the same submission
K013977 also covers:
- Echo-Screen Hearing Screening Supplies — Natus Medical Incorporated
- Natus — Natus Medical Incorporated
- Natus — Natus Medical Incorporated
- Natus — Natus Medical Incorporated
- Natus — Natus Medical Incorporated
- Natus — Natus Medical Incorporated
- Natus — Natus Medical Incorporated
- Natus — Natus Medical Incorporated
- Natus — Natus Medical Incorporated
- Natus — Natus Medical Incorporated
- Natus — Natus Medical Incorporated
- Natus — Natus Medical Incorporated
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Natus Medical Incorporated
Sources (1)
- FDA UDI e8d451c4-4eb4-469b-9147-1fbc93f75e1c 37 fields · synced Jun 8, 2026