WomanCare Global Ipas MVA Plus Aspirator

Basic Information

• Brand Name: WomanCare Global Ipas MVA Plus Aspirator
• Primary DI: 00853615006260
• Version / Model: PLUS
• Company Name: WOMANCARE GLOBAL TRADING, INC.
• Labeler DUNS: 064730456
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-07
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 4a0713ae-5179-49d5-ab57-621d23f091b1

Device Description

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.

Device Characteristics

• Single Use: No
• 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: Yes
• Sterilization Methods: ["Moist Heat or Steam Sterilization", "High-level Disinfectant", "Liquid Chemical"]

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
62162	Abortion suction system manual aspirator	A non-sterile, manual, syringe-like device intended to be used in conjunction with an intrauterine cannula (not included) to aspirate fluid from the uterus for treatment of incomplete abortion, first trimester abortion, and/or for menstrual regulation; it may also be intended for endometrial biopsy. It includes a plunger with syringe barrel and appropriate connectors, seals, and valves, whereby fluid is intended to be aspirated directly into the barrel (i.e., not via a collection bottle). This is a reusable device after appropriate cleaning/disinfection.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853615006260	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Diameter from Valve Button to Valve Button: 15 cm.
Device Size Text, specify			Handle Width: 8 cm.
Width	6.5	Centimeter
Device Size Text, specify			Length from Nose Cone to Handle: 26 cm.
Device Size Text, specify			Height is 5cm at Valve Body, with 60cc Volume

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius