The device is used to evacuate the contents of the uterus, or to obtain specimens for pathological examination. The aspirator consists of a 60cc syringe barrel (with graduations), plastic…
The device is used to evacuate the contents of the uterus, or to obtain specimens for pathological examination. The aspirator consists of a 60cc syringe barrel (with graduations), plastic plunger with an ergonomically-designed handle, a plunger, a rubber o-ring, a collar stop, a plastic double-locking valve with removable silicone liner, and valve cover. Aspirators are clean, not sterile, and reusable at a maximum of 25 times. The package contains one aspirator and one 2cc silicone tube.
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 Ipas MVA Plus 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 | 2016-09-07 |
| Record revised | 2018-03-29 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | Moist Heat or Steam Sterilization, High-level Disinfectant, Liquid Chemical |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 15 to 30 °C |
| Sizes | Width 6.5 cm |
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.