FDA UDI
In Commercial Distribution
🇺🇸 United States
WomanCare Global Single-Valve Aspirator
DI: 00853615006352
·
Model: SVS-S10
·
WOMANCARE GLOBAL TRADING, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- WomanCare Global Single-Valve Aspirator
- Primary DI
- 00853615006352
- Version / Model
- SVS-S10
- Company Name
- WOMANCARE GLOBAL TRADING, INC.
- Labeler DUNS
- 064730456
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-17
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 21a3e6d3-8db9-46c6-87f7-6bdac2b89d24
Device Description
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HHI | System, Abortion, Vacuum | Obstetrics/Gynecology | 884.5070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33577 | Abortion suction system collection bottle | A component of an abortion (uterine) suction system designed to function as a trap to collect the products of conception from the uterus [the termination of early pregnancies (up to 12 weeks), the treatment of incomplete spontaneous abortions, the removal of retained afterbirth, menstrual regulation, or biopsy]. It is typically cylindrical in shape and connected to a wide bore tubing through which the removed material is suctioned. It may have an integrated filter made of woven textile that acts as a sieve and trap (blood passes through whilst solids are retained). This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853615006352 | GS1 | ||||
| Package | 10853615006359 | GS1 | Box | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +1-858-314-4030
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 3.5 | Inch | |
| Length | 8.5 | Inch | |
| Total Volume | 60 | Milliliter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius