WomanCare Global Single-Valve Aspirator Accessory Kit

Basic Information

• Brand Name: WomanCare Global Single-Valve Aspirator Accessory Kit
• Primary DI: 00853615006321
• Version / Model: AK-SVS
• 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: 60be1228-64ce-48fd-8a9a-4cca3ef0e77e

Device Description

Accessory kits are bagged and each kit contains: collar stop, plunger, o-ring and 2cc silicone tube. The cap, collar stop and o-ring, as components, are suitable to 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
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	00853615006321	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Lubricant: 2cc tube
Device Size Text, specify			Collar Stop length: 3 inches
Device Size Text, specify			Ring Diameter: 1 inch

Storage Conditions

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