WomanCare Global Miscarriage Management Kit

Basic Information

• Brand Name: WomanCare Global Miscarriage Management Kit
• Primary DI: 00853615006291
• Version / Model: MMK-SU
• 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: 6dcc2331-4571-495c-924d-7b0154580428

Device Description

Each kit contains one Ipas Double-Valve Aspirator, 4 Ipas EasyGrip® Cannulae: 6mm, 7mm, 8mm, and 9mm, 3 Denniston Dilators: 5/6mm, 7/8mm, and 9/10mm.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
47341	Intrauterine curette, suction	A sterile, tubular, semi-rigid, hand-held device used to scrape the lining of the uterus for the removal of tissue during a gynaecological procedure, typically for the removal of an early or non-viable embryo/foetus. The device typically has a rounded blunt nose and an opening(s) with a blunt scraping edge(s) at the distal end. It is connected at the proximal end to tubing and a suction source, typically an abortion suction system, which provides regulated suction. Also known as a pregnancy termination catheter, it is typically made of plastic and is available in various shapes and sizes. This is a single-use device.	No	Active
47987	Fixed-diameter cervical dilator, single-use	A rod-like, solid surgical instrument designed to dilate the cervical canal after its insertion through the cervical os. Commonly known as a uterine dilator, it is typically made of metal or plastic material and has a tapered, rounded distal tip. It may have one diameter or two different size diameters, one at each end of the instrument. The device is typically available in a set of graduated sizes that are applied in succession. It is used to allow the passage of a curette or other instruments into the uterus and/or enlarge the uterus prior to surgical intervention by pressing on the inner walls of the uterus. This is a single-use device.	No	Active
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	00853615006291	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Dilators: 5/6mm, 7/8mm, 9/10mm
Device Size Text, specify			Cannulae: 223mm long and 0.5mm to 1.3mm in thickness
Device Size Text, specify			Double-Valve Aspirator: 9in long and 3.5in in diameter

Storage Conditions

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