The device is used to evacuate the contents of the uterus. It consists of a 60cc syringe barrel, plunger, collar stop, o-ring, and removable valve liner. Aspirators are compatible with…
The device is used to evacuate the contents of the uterus. It consists of a 60cc syringe barrel, plunger, collar stop, o-ring, and removable valve liner. Aspirators are compatible with cannulae size 3-6mm. Aspirator is sterile, clean, and single use.
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for WomanCare Global Single-Valve Aspirator | Listed by | Womancare Global Trading, Inc. |
| FDA product code | HHI |
| Device type | System, Abortion, Vacuum |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5070 |
| Premarket notification | Exempt |
| Record published | 2016-09-17 |
| Record revised | 2018-03-29 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | High-level Disinfectant, Liquid Chemical |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 15 to 30 °C |
| Packaging | Box of 10 |
| Sizes | Outer diameter 3.5 in; length 8.5 in; total volume 60 ml |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.