| Primary Device ID | 15060498950333 |
| NIH Device Record Key | e6331a19-c773-49e3-b22a-d5ea73d8328c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dosing System |
| Version Model Number | ZX1000 |
| Company DUNS | 220440619 |
| Company Name | EUROPLAZ TECHNOLOGIES LTD |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060498950336 [Primary] |
| GS1 | 15060498950333 [Package] Contains: 05060498950336 Package: Cardboard carton [4 Units] In Commercial Distribution |
| PXA | Oral Administration Set |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-09 |
| Device Publish Date | 2026-01-31 |
| 15060498950333 - Dosing System | 2026-02-09Mixing Bottle & Dosing Cup |
| 15060498950333 - Dosing System | 2026-02-09 Mixing Bottle & Dosing Cup |
| 15060498950340 - Procedure Pack | 2026-02-09 ZX1000 Mixing Bottle & Dosing Cup + Two Rovipharm 26489151 Oral Dosing Syringes |