| Primary Device ID | 16945060530023 |
| NIH Device Record Key | 53ffb40c-03de-4479-926f-7dbb46064979 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | I.V. Catheter |
| Version Model Number | Y Type-03(8G/30mm) |
| Company DUNS | 530079367 |
| Company Name | Jiang Xi Sanxin Medtec Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06945060530026 [Primary] |
| GS1 | 16945060530023 [Package] Contains: 06945060530026 Package: [50 Units] In Commercial Distribution |
| GS1 | 26945060530020 [Package] Package: [4 Units] In Commercial Distribution |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-27 |
| Device Publish Date | 2025-03-19 |
| 16945060530023 | The proposed device, l.V, Catheter, is intended to be inserted in to a patient's vascular system |
| 16945060530016 | The proposed device, l.V, Catheter, is intended to be inserted in to a patient's vascular system |