| Primary Device ID | 00814079021398 |
| NIH Device Record Key | 32d3c124-c324-4d6d-a370-68b3d71fc36a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Amaryll Start |
| Version Model Number | 63.00.191 |
| Catalog Number | 63.00.191 |
| Company DUNS | 481670396 |
| Company Name | Ardo medical AG |
| 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 | false |
| 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 | true |
| Phone | +41417547070 |
| info@ardo.ch | |
| Phone | +41417547070 |
| info@ardo.ch |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814079021381 [Primary] |
| GS1 | 00814079021398 [Package] Contains: 00814079021381 Package: Box [10 Units] In Commercial Distribution |
| HGY | Pump, Breast, Non-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-25 |
| Device Publish Date | 2018-09-24 |
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