| Primary Device ID | EDET022711 |
| NIH Device Record Key | 860d7d27-1fec-4085-8665-5da105687238 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | detax addition blue 2 x 5000 ml |
| Version Model Number | 02271 |
| Company DUNS | 343947949 |
| Company Name | DETAX GmbH |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EDET022711 [Primary] |
| ESD | Hearing Aid, Air-Conduction, Prescription |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-10 |
| Device Publish Date | 2023-06-30 |
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