IVC-THREE Blastocyst Medium 2007-V

GUDID 00859268006107

IVC-THREE Blastocyst Medium is a synthetic, defined culture medium composed of a balanced mixture of salts, amino acid, vitamins and other nutrients designed to support embryo growth and blastocyst development in vitro. IVC-THREE Blastocyst Medium has been formulated without phosphate, which may be detrimental to blastocyst development (Quinn P, Moinipanah R, Steinberg J, Weathersbee P: Fertil Steril 1995;63:922-924). IVC-THREE Blastocyst Medium may be used as a stand alone medium or as the second stage of a sequential medium protocol.

INVITROCARE, INCORPORATED

IVF medium
Primary Device ID00859268006107
NIH Device Record Keyd4e0deb2-4e23-43c5-b009-f7a06c001223
Commercial Distribution StatusIn Commercial Distribution
Brand NameIVC-THREE Blastocyst Medium
Version Model Number2007-V
Catalog Number2007-V
Company DUNS190094230
Company NameINVITROCARE, INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100859268006107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQLMedia, Reproductive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

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