WomanCare Global Adapter Set

Basic Information

• Brand Name: WomanCare Global Adapter Set
• Primary DI: 00853615006345
• Version / Model: ADP-SET
• 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: d03e80f0-c4b8-4cf4-8d61-1b3f85b3a570

Device Description

Adapters are packed in a sealed bag containing one each the following sizes: 6, 7, 8, 9, and 10mm. Adapters are compatible with the WomanCare Global Ipas MVA Plus® Aspirator. Adapters are color-coded using a different color for each size, 6mm (blue), 7mm (light brown), 8mm (white), 9mm (dark brown), and 10mm (green). Adapters have wings for facilitation of adding and removing from aspirator. Adapters can be reused a maximum of 25 times.

Device Characteristics

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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HGH	Cannula, Suction, Uterine	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
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853615006345	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			5th Adapter: 10mm diameter, 1 inch length
Device Size Text, specify			4th Adapter: 9mm diameter, 1 inch length
Device Size Text, specify			3rd Adapter: 8mm diameter, 1 inch length
Device Size Text, specify			2nd Adapter: 7mm diameter, 1 inch length
Device Size Text, specify			1st Adapter: 6mm diameter, 1 inch length

Storage Conditions

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