Sanibel Supply
Audiometric foam ear tip
1manufacturer
56catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong Kelihuan Biotechnology Co., Ltd. | Huizhou | Guangdong | Manufacturer | 5 |
Record
| Listed by | Interacoustics A/S, Denmark |
|---|---|
| FDA product code | ETT |
| Device type | Cushion, Earphone (For Audiometric Testing) |
| Device class | Class 1 |
| Regulation | 21 CFR 874.1100 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
| Record revised | 2025-06-30 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 5 to 27 °C |
| Packaging | Pack of 100, pack of 25, pack of 750, pack of 50, pack of 10, pack of 20 |
| Sizes | Outer diameter 7 to 18 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Pediatric OAE foam ear tips | In distribution | ||
| Sanibel foam tip, small, peadiatric pink | In distribution | ||
| ANA-Infant Tree, yellow | In distribution | ||
| Sanibel foam tip, medium, adult pink | In distribution | ||
| Audiometric foam ear tip | Outer Diameter 18 mm | In distribution | |
| Ear tip, mushroom 15 mm, blue | In distribution | ||
| Sanibel™ ADI Ear Tip Kit | In distribution | ||
| Sanibel foam tip, large, Jumbo pink | In distribution | ||
| Ear tip 5 mm, AOT-5.0 light blue | In distribution | ||
| Ear tip, mushroom 7mm, blue | Outer Diameter 7 mm | In distribution | |
| ADI eartip sample kit | In distribution | ||
| Ear tip 4-7 mm, AOT 4-7 transparent | In distribution | ||
| Ear tip, mushroom 12 mm, yellow | In distribution | ||
| Ear tip Infant C, transparent | In distribution | ||
| AuDX Infant ear tip 6 mm, light blue | In distribution | ||
| Ear tip, umbrella 9 mm, green | In distribution | ||
| Ear tip infant 4 mm, ANA-4.0, blue | In distribution | ||
| Ear tip, umbrella 15 mm, red | In distribution | ||
| Flanged infant eartips 3-5 mm, red | In distribution | ||
| Ear tip, umbrella 10 mm, blue | In distribution | ||
| Ear tip, mushroom 11 mm, blue | In distribution | ||
| Ear tip, umbrella 22 mm, yellow | In distribution | ||
| Ear tip, OAE-4 ER Infant, 4 mm red flanged | In distribution | ||
| Ear tip, umbrella 7,5 mm, green | In distribution | ||
| Ear tip, mushroom 14 mm, red | In distribution | ||
| Ear tip Infant A, transparent | In distribution | ||
| Jumbo OAE foam ear tips | In distribution | ||
| AuDX Preemie ear Tip 3 mm, light red | In distribution | ||
| Sanibel ADI Scre. Ear Tip Kit | In distribution | ||
| Preemie Ear tip, green | In distribution | ||
| Ear tip 4 mm, AOT-4.0 green | In distribution | ||
| Flanged infant eartips 4-7 mm, blue | In distribution | ||
| Ear tip, mushroom 8 m, yellow | Outer Diameter 8 mm | In distribution | |
| SnapPROBE™ Accessories box | In distribution | ||
| Ear tip 4.5 mm, AOT-4.5 pink | In distribution | ||
| Ear tip, umbrella 13 mm, green | In distribution | ||
| Ear tip, mushroom 13 mm, green | In distribution | ||
| ADI eartip sample kit, Oaktree | In distribution | ||
| EarTurtle, Slide | 2 | In distribution | |
| Flanged infant eartips 5-8 mm, yellow | In distribution | ||
| Adult OAE foam ear tips | In distribution | ||
| Ear tip, umbrella 19 mm, blue | In distribution | ||
| Ear tip, mushroom 10 mm, red | In distribution | ||
| AuDX Tree ear tip 3,5-5 mm transparent | In distribution | ||
| Ear tip infant 5 mm, ANA-5.0, green | In distribution | ||
| Ear tip 3.7 mm, AOT-3.7 yellow | In distribution | ||
| Ear tip infant 4,5 mm, ANA-4.5, red-brown | In distribution | ||
| Ear tip, OAE-3, 3 mm yellow | In distribution | ||
| Ear tip, umbrella 11 mm, yellow | In distribution | ||
| EARturtle | 2 | In distribution | |
| Ear tip, mushroom 19 mm, yellow | In distribution | ||
| Ear tip, mushroom 9 mm, green | In distribution | ||
| Assortment BET55 Complete | In distribution | ||
| ADI eartip sample kit, E3 | In distribution | ||
| Assortment Box BET25 | In distribution | ||
| ANA Infant mushroom ear tip, green | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Grason & Associates, LLC | Grason & Associates, LLC | 144 |
| OAE Eartips | Natus Medical Denmark ApS | 9 |
| E-A-Rlink™ | 3M Company | 8 |
| Sanibel Supply A/S | Interacoustics A/S | 5 |
| Maico | Interacoustics A/S | 3 |
| GoCheck Audiometric Headphone Assembly | Gobiquity, Inc. | 2 |
| Infant E-A-Rtip | 3M Company | 2 |
| Amplivox | Interacoustics A/S | 2 |
| Etymotic | Etymotic Research, Inc. | 2 |
| Foam Eartip 3C (Jumbo) | Natus Manufacturing Limited | 1 |
| Interacoustics | Interacoustics A/S | 1 |
| Foam Eartip, 3B (Small) | Natus Manufacturing Limited | 1 |
Showing 12 of 13. All products under Cushion, Earphone (For Audiometric Testing)
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.