IVC-TWO

Primary DI
00859268006091
Brand
IVC-TWO
Company
INVITROCARE, INCORPORATED
Model
2008-V
Catalog number
2008-V
Device description
IVC-TWO is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures.The formulation of IVC-TWO is substantially equivalent to the glucose and phosphate free HTF formulation published by Quinn et al (Quinn P, Moinipanah R, Steinberg J, Weathersbee P: Fertil Steril 1995;63:922-924). IVC-TWO is designed to support early stages of embryonic growth (up to four days post-fertilization). IVC-TWO has been formulated without phosphate, which may be detrimental to embryo blastocyst development. IVC-TWO may be used as a stand alone medium or as the first stage of a sequential medium protocol.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQLMedia, Reproductive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQLMedia, ReproductiveObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000937000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000937000IVC TWO MEDIUMInvitrocare, Inc.2000-05-25MQL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859268006091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859268006091008592680060918592680060910859268006091

GMDN Terms#

Term, Definition table
TermDefinition
IVF mediumA solution that provides a physiological environment for the retrieval, culture, maintenance, transfer, and/or storage of human sperm, harvested oocytes (eggs), and/or resulting embryos associated with the method of in vitro fertilization (IVF). The solution typically contains various combinations of salts, carbohydrates, amino acids, enzymes, hormones, albumin, vitamins, and/or drugs (e.g., antibiotics). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
190094230
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859268006329SPERM FREEZING MEDIUM - SpermFreeze2230-502230-502026-01-15
00859268006237SPERM FREEZING MEDIUM - SpermFreeze223022302016-09-24
00859268006312PVP - Polyvinylpyrrolidone2210-502025-10-02
00859268006305HYALURONIDSE2212-102212-102022-07-29
00859268006275HTF HEPES2002-L2002-L2021-11-04
00859268006282SPERM WASH MEDIUM2005-L2005-L2021-11-04
10859268006043SPERM WASH MEDIUM200320032016-09-24
10859268006128HUMAN SERUM ALBUMIN210121012016-09-24
10859268006241SPERMCARE / SPERM WASH - Gradient System222422242016-09-24
10859268006258SPERM WASH MEDIUM for Swim-Up262026202016-09-24
00859268006008HTF culture medium200120012016-09-24
00859268006015HTF HEPES200220022016-09-24
00859268006022HTF HEPES2002-52002-52016-09-24
00859268006039SPERM WASH MEDIUM2003-12003-12016-09-24
00859268006053SPERM WASH MEDIUM200520052016-09-24
00859268006060SPERM WASH MEDIUM2005-52005-52016-09-24
00859268006077SPERM WASH MEDIUM2003-K22003-K22016-09-24
00859268006084SPERM WASH MEDIUM2003-K752003-K752016-09-24
00859268006107IVC-THREE Blastocyst Medium2007-V2007-V2016-09-24
00859268006114HUMAN SERUM ALBUMIN2101-12101-12016-09-24

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