AccessGUDID - DEVICE: WomanCare Global Ipas MVA Plus Aspirator (00853615006260)

GUDID

Device Identifier (DI) Information

Brand Name: WomanCare Global Ipas MVA Plus Aspirator
Version or Model: PLUS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WOMANCARE GLOBAL TRADING, INC.

Primary DI Number: 00853615006260
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064730456 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HHI	System, Abortion, Vacuum

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization
High-level Disinfectant
Liquid Chemical

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type 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

Device Record Status

Public Device Record Key: 4a0713ae-5179-49d5-ab57-621d23f091b1
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 07, 2016