FDA.reportPublic FDA data

WomanCare Global Ipas MVA Plus Aspirator

Primary DI
00853615006260
Brand
WomanCare Global Ipas MVA Plus Aspirator
Company
WOMANCARE GLOBAL TRADING, INC.
Model
PLUS
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.
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HHISystem, Abortion, Vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHISystem, Abortion, VacuumObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853615006260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853615006260008536150062608536150062600853615006260

GMDN Terms#

Term, Definition table
TermDefinition
Abortion suction system manual aspiratorA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Width6.5Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""High-level Disinfectant"", ""Liquid Chemical""]"
Moist Heat or Steam Sterilization;High-level Disinfectant;Liquid Chemical

Contacts#

Phone, Email table
PhoneEmail
+1-858-314-4030customerservice@womancareglobal.org

Regulatory Flags#

DUNS number
064730456
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853615006000WomanCare Global Flexible Karman Cannula, 10mmFC102016-09-17
00853615006024WomanCare Global Flexible Karman Cannula, 12mmFC122016-09-17
00853615006031WomanCare Global Flexible Karman Cannula, 4mm FC42016-09-17
00853615006048WomanCare Global Flexible Karman Cannula, 5mmFC52016-09-17
00853615006055WomanCare Global Flexible Karman Cannula, 6mmFC62016-09-17
00853615006062WomanCare Global Flexible Karman Cannula, 7mmFC72016-09-17
00853615006079WomanCare Global Flexible Karman Cannula, 8mmFC82016-09-17
00853615006086WomanCare Global Flexible Karman Cannula, 9mmFC92016-09-17
00853615006093WomanCare Global Ipas EasyGrip® Cannula, 10mmSR102016-09-17
00853615006109WomanCare Global Ipas EasyGrip® Cannula, 10mmSR10-SU2016-09-17
00853615006116WomanCare Global Ipas EasyGrip® Cannula, 12mmSR122016-09-17
00853615006123WomanCare Global Ipas EasyGrip® Cannula, 12mmSR12-SU2016-09-17
00853615006130WomanCare Global Ipas EasyGrip® Cannula, 4mmSR42016-09-17
00853615006147WomanCare Global Ipas EasyGrip® Cannula, 4mmSR4-SU2016-09-17
00853615006154WomanCare Global Ipas EasyGrip® Cannula, 5mmSR52016-09-17
00853615006161WomanCare Global Ipas EasyGrip® Cannula, 5mmSR5-SU2016-09-17
00853615006178WomanCare Global Ipas EasyGrip® Cannula, 6mmSR62016-09-17
00853615006185WomanCare Global Ipas EasyGrip® Cannula, 6mmSR6-SU2016-09-17
00853615006192WomanCare Global Ipas EasyGrip® Cannula, 7mmSR72016-09-17
00853615006208WomanCare Global Ipas EasyGrip® Cannula, 7mmSR7-SU2016-09-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
GYNX31301GynexGYNEX CORPORATIONHHI2023-12-26
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GYNX31300GynexGYNEX CORPORATIONHHI2023-12-26
GYNX31350GynexGYNEX CORPORATIONHHI2023-12-26
04055207040027NARichard Wolf GmbHHHI2022-10-27
M803022721MedGyn Pipette MEDGYN PRODUCTS, INC.HHI2020-12-14
M803022730MedGyn Pipette IV MEDGYN PRODUCTS, INC.HHI2020-12-14
M803022734MedGyn Pipette IIMEDGYN PRODUCTS, INC.HHI2020-12-14
00821925030862Gyrus ACMIGyrus ACMI, LLCHHI2017-05-10
00821925000247003997-901 Gauze Sack and O-RingGyrus Acmi, Inc.HHI2017-05-10
00821925009561GYRUS ACMIGyrus ACMI, LLCHHI2017-05-09
00821925010475BERKELEYGyrus ACMI, LLCHHI2016-10-18
00821925008632Berkeley 1/2" Collection SetGyrus Acmi, Inc.HHI2016-10-13
00821925008625BERKELEY 1/2" (13mm) PRIMARYGyrus Acmi, Inc.HHI2016-10-13
00821925004184Collection Set, Disposable with Handle and Tapered Fitting Tubing 6 fGyrus Acmi, Inc.HHI2016-10-11
00821925000919VACURETTE CURVED 8MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11
0082192500094021163 Permeable Gauze Sacks (10/Pkg)Gyrus Acmi, Inc.HHI2016-10-11
00821925000964VACURETTE STRAIGHT 9MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11
00821925000971VACURETTE STRAIGHT 10MM 10PKGGyrus Acmi, Inc.HHI2016-10-11
00821925000988VACURETTE STRAIGHT 11MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11
00821925000995VACURETTE STRAIGHT 12MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11
00821925001015VACURETTE CURVED 9MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11
00821925001022VACURETTE CURVED 10MMGyrus Acmi, Inc.HHI2016-10-11
00821925001039VACURETTE CURVED 11MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11
00821925001046VACURETTE CURVED 12MM-10/PKGGyrus Acmi, Inc.HHI2016-10-11
00821925004689VACURETTE STRAIGHT 16MM 10/PKGyrus Acmi, Inc.HHI2016-10-11
00821925004702VACURETTE CURVED 16MM 10/PKGyrus Acmi, Inc.HHI2016-10-11
00821925004719VACURETTE STRAIGHT 8MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11
00821925004726VACURETTE "F" TIP 4MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11
00821925004597VACURETTE "F" TIP 5MM 10/PKGGyrus Acmi, Inc.HHI2016-10-11