| Primary Device ID | 05713315012075 |
| NIH Device Record Key | be79e488-90bf-453a-b4be-b5c7eb0d7a5c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OAE Eartips |
| Version Model Number | 203201 |
| Company DUNS | 306633756 |
| Company Name | Natus Medical Denmark ApS |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05713315012075 [Primary] |
| ETT | Cushion, Earphone (For Audiometric Testing) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-30 |
| Device Publish Date | 2025-12-22 |
| 05713315012150 | OAE Preemie TreeTip (100) |
| 05713315012143 | OAE TreeTip (100) |
| 05713315012136 | OAE Adult Foam Tip (100) |
| 05713315012129 | OAE Pediatric Foam Tip (100) |
| 05713315012112 | OAE Jumbo Foam Tip (100) |
| 05713315012105 | OAE Preemie TreeTip (20) |
| 05713315012099 | OAE TreeTip (20) |
| 05713315012082 | OAE Adult Foam Tip (20) |
| 05713315012075 | OAE Pediatric Foam Tip (20x) |