| Primary Device ID | 00850022464621 |
| NIH Device Record Key | b8797145-42cb-4d36-b7c7-fa1049346959 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | hearX Group |
| Version Model Number | hearOAE |
| Company DUNS | 539177681 |
| Company Name | HEARX GROUP (PTY) LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850022464621 [Primary] |
| EWO | Audiometer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-12 |
| Device Publish Date | 2025-03-04 |
| 00850022464621 - hearX Group | 2025-03-12The hearOAE (otoacoustic emission device) is a portable, handheld, battery-operated device that can detect hearing loss using Otoacoustic Emission technologies. The hearOAE device may be configured to support one or any combination of TEOAE (transient evoked otoacoustic emissions) or DPOAE (distortion product otoacoustic emissions). |
| 00850022464621 - hearX Group | 2025-03-12 The hearOAE (otoacoustic emission device) is a portable, handheld, battery-operated device that can detect hearing loss using Ot |
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