Duns Number:190094230
Device Description: IVC-TWO is a synthetic, defined culture medium intended for use in assisted reproductive t 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.
Catalog Number
2008-V
Brand Name
IVC-TWO
Version/Model Number
2008-V
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K000937
Product Code
MQL
Product Code Name
Media, Reproductive
Public Device Record Key
f9ae26ef-8ab7-415e-8893-3a08a85bc40e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 29 |