| Primary Device ID | 06970462546825 |
| NIH Device Record Key | 339f4645-cac2-4162-ad3b-51e71d3db7c7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Irrigation Pump |
| Version Model Number | PP-01 |
| Company DUNS | 403655303 |
| Company Name | Shenzhen HugeMed Medical Technical Development 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 | false |
| Serial Number | true |
| 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 | 06970462546825 [Primary] |
| FQH | Lavage, Jet |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-18 |
| Device Publish Date | 2026-02-10 |
| 16970462546716 - Broncho Sampler | 2026-02-18 |
| 06970462546825 - Irrigation Pump | 2026-02-18 |
| 06970462546825 - Irrigation Pump | 2026-02-18 |
| 06970462546849 - Stone Collector | 2026-02-18 |
| 16970462546853 - Stone Collector | 2026-02-18 |
| 16970462547454 - Single-use Ureteral Access Sheath | 2026-02-18 |
| 16970462547461 - Single-use Ureteral Access Sheath | 2026-02-18 |
| 16970462547478 - Single-use Ureteral Access Sheath | 2026-02-18 |
| 16970462547485 - Single-use Ureteral Access Sheath | 2026-02-18 |