| Primary Device ID | 26938634491780 |
| NIH Device Record Key | 02f0b4c9-20c6-4894-afc3-bc587a954dca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Disposable Hemodialysis Access Catheter Set Double |
| Version Model Number | R2Z-FR-2612 |
| 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 | 06938634491786 [Primary] |
| GS1 | 16938634491783 [Package] Contains: 06938634491786 Package: [10 Units] In Commercial Distribution |
| GS1 | 26938634491780 [Package] Contains: 16938634491783 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 |