WomanCare Global Ipas MVA Plus Aspirator

GUDID 00853615006260

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.

WOMANCARE GLOBAL TRADING, INC.

Abortion suction system manual aspirator
Primary Device ID00853615006260
NIH Device Record Key4a0713ae-5179-49d5-ab57-621d23f091b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameWomanCare Global Ipas MVA Plus Aspirator
Version Model NumberPLUS
Company DUNS064730456
Company NameWOMANCARE GLOBAL TRADING, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1-858-314-4030
Emailcustomerservice@womancareglobal.org

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100853615006260 [Primary]

FDA Product Code

HHISystem, Abortion, Vacuum

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00853615006260]

Moist Heat or Steam Sterilization;High-level Disinfectant;Liquid Chemical


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-07

Devices Manufactured by WOMANCARE GLOBAL TRADING, INC.

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00853615006031 - WomanCare Global Flexible Karman Cannula, 4mm 2018-03-29 A flexible, sterile cannula with two "whistle cut" type openings with no sharp edges. Cannula feature dots as indicators for mea
00853615006048 - WomanCare Global Flexible Karman Cannula, 5mm2018-03-29 A flexible, sterile cannula with two "whistle cut" type openings with no sharp edges. Cannulae feature dots as indicators for me
00853615006055 - WomanCare Global Flexible Karman Cannula, 6mm2018-03-29 A flexible, sterile cannula with two "whistle cut" type openings with no sharp edges. Cannulae feature dots as indicators for me
00853615006062 - WomanCare Global Flexible Karman Cannula, 7mm2018-03-29 A flexible, sterile cannula with two "whistle cut" type openings with no sharp edges. Cannulae feature dots as indicators for me
00853615006079 - WomanCare Global Flexible Karman Cannula, 8mm2018-03-29 A flexible, sterile cannula with two "whistle cut" type openings with no sharp edges. Cannulae feature dots as indicators for me
00853615006086 - WomanCare Global Flexible Karman Cannula, 9mm2018-03-29 A flexible, sterile cannula with a single large "scoop cut" type opening with no sharp edges. Cannulae feature dots as indicator

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