| Primary Device ID | 06975183900086 |
| NIH Device Record Key | 5f10b44a-9023-4148-8ac2-3349e80f2550 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HARIOMED |
| Version Model Number | Harioculture HI-2 |
| Company DUNS | 625413598 |
| Company Name | Hua Yue Medical Technology 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 | true |
| 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 | 06975183900086 [Primary] |
| PUB | Accessory, Assisted Reproduction, Exempt |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-24 |
| Device Publish Date | 2025-03-14 |
| 06975183900130 | IW-A1800D |
| 06975183900116 | IW-A1800S |
| 06975183900109 | IW-A1800 |
| 06975183900093 | Harioculture HI-4 |
| 06975183900086 | Harioculture HI-2 |
| 06975183900079 | Harioculture DI-4 |
| 06975183900062 | IBI-D101 |
| 06975183900055 | IMS-320U-S |
| 06975183900048 | IMS-320D-S |
| 06975183900031 | IMS-320U |
| 06975183900024 | IMS-320D |
| 06975183900178 | IW-A1350S |
| 06975183900161 | IW-A1350C |
| 06975183900154 | IW-A1350A |
| 06975183900147 | IW-A950 |
| 06975183900123 | IW-A1800M |