| Primary Device ID | 06971919461395 |
| NIH Device Record Key | b9c44b49-5887-4ed6-92c8-87cf9eb31dba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PREMIUM |
| Version Model Number | 2L |
| Company DUNS | 543014978 |
| Company Name | Ningbo Albert Novosino Co.,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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06971919461395 [Primary] |
| FCE | Enema Kit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-19 |
| Device Publish Date | 2024-03-11 |
| 06971919461401 | 2L |
| 06971919461395 | 2L |