| Primary Device ID | 00860001471731 |
| NIH Device Record Key | 6da04446-8d86-4ccd-9c0f-49d0fc7c09a4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Miracle Ear App |
| Version Model Number | Android v3 |
| Company DUNS | 428013775 |
| Company Name | AMPLIFON SPA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 866-396-3749 |
| app@miracle-ear.com | |
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| app@miracle-ear.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860001471731 [Primary] |
| OSM | Hearing Aid, Air Conduction With Wireless Technology |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-08 |
| Device Publish Date | 2021-03-31 |
| 00860001471731 | Android v3 |
| 00860001471724 | iOS v3 |