| Primary Device ID | 26938634496273 |
| NIH Device Record Key | 1bde00bb-26af-4685-8d81-ed4b7401cf4f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Disposable Hemodialysis Access Catheter Set Single |
| Version Model Number | H2Z-FH-1715 |
| Company DUNS | 547055364 |
| Company Name | Guangdong Baihe Medical Technology 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06938634496279 [Primary] |
| GS1 | 16938634496276 [Package] Contains: 06938634496279 Package: [10 Units] In Commercial Distribution |
| GS1 | 26938634496273 [Package] Contains: 16938634496276 Package: [40 Units] In Commercial Distribution |
| MPB | Catheter, Hemodialysis, Non-Implanted |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-22 |
| 26938634496303 | H2Z-FH-1816 |
| 26938634496297 | H2Z-FH-1815 |
| 26938634496280 | H2Z-FH-1814 |
| 26938634496273 | H2Z-FH-1715 |
| 26938634496266 | H2Z-FH-1714 |
| 26938634496259 | H2Z-FH-1713 |
| 26938634496242 | H2Z-FH-1712 |
| 26938634492862 | H2Z-FH-1813 |
| 26938634492855 | H2Z-FH-1716 |
| 26938634490387 | H2Z-FH-1812 |
| 26938634490370 | H2Z-FH-1811 |