| Primary Device ID | 50810011730477 |
| NIH Device Record Key | ade4902d-91de-4d6f-9194-e6a0c47724b6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Seren Guard |
| Version Model Number | safety type |
| Company DUNS | 421272490 |
| Company Name | Tianjin Huahong Technology Co., Ltd. |
| Device Count | 100 |
| 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 | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810011730472 [Primary] |
| GS1 | 50810011730477 [Unit of Use] |
| FMI | Needle, Hypodermic, Single Lumen |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-15 |
| Device Publish Date | 2023-11-07 |
| 10810011730639 - Huahong | 2025-07-31 |
| 00810011730601 - Sinocare | 2025-06-27 |
| 10810011730615 - Advocate | 2025-06-27 |
| 30810011730336 - Care Touch | 2025-05-01 |
| 50810011730590 - LinkSun | 2025-05-01 |
| 10810011730523 - GlucoDr. | 2025-04-24 |
| 50810011730583 - LinkSun | 2025-03-10 |
| 10810011730554 - BKG | 2024-11-01 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SEREN GUARD 90184598 not registered Live/Pending |
Prime Pace Products, LLC 2020-09-16 |