V-VITWARM

GUDID 04260650070297

V VITWARM is a ready-to-use kit to thaw human oocytes and embryos (up to blastocyst stage) which are cryopreserved. Subsequently, the thawed oocytes and embryos can be used in Assisted Reproduction Technology (ART) processes. There are in total 4 vials of pink solutions in the package: - 2 vials of Thawing Solution (TS), with red caps and labels. - 1 vial of Diluent Solution (DS), with a yellow cap and label. - 1 vial of Washing Solution (WS), with a white cap and label. V-VITWARM is intended for use in the thawing of vitrified of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.

VITROMED GmbH

IVF medium
Primary Device ID04260650070297
NIH Device Record Key6145fba5-108d-4379-adb4-98d486349f33
Commercial Distribution StatusIn Commercial Distribution
Brand NameV-VITWARM
Version Model NumberV-TS-KIT
Company DUNS315234102
Company NameVITROMED GmbH
Device Count4
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260650070297 [Unit of Use]
GS104260650070341 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-25
Device Publish Date2024-11-16

Devices Manufactured by VITROMED GmbH

04260650070297 - V-VITWARM2024-11-25V VITWARM is a ready-to-use kit to thaw human oocytes and embryos (up to blastocyst stage) which are cryopreserved. Subsequently, the thawed oocytes and embryos can be used in Assisted Reproduction Technology (ART) processes. There are in total 4 vials of pink solutions in the package: - 2 vials of Thawing Solution (TS), with red caps and labels. - 1 vial of Diluent Solution (DS), with a yellow cap and label. - 1 vial of Washing Solution (WS), with a white cap and label. V-VITWARM is intended for use in the thawing of vitrified of oocytes (MII), pronuclear (PN) zygotes through day 3 cleavage stage embryos and blastocyst stage embryos.
04260650070297 - V-VITWARM2024-11-25 V VITWARM is a ready-to-use kit to thaw human oocytes and embryos (up to blastocyst stage) which are cryopreserved. Subsequently
04260650070273 - V-VITFREEZE2024-10-24 V-VITFREEZE is a ready-to-use kit to cryopreserve human oocytes and embryos (up to blastocyst stage) in Assisted Reproduction Te
04260650071034 - V-PVP2024-05-13 V-PVP is a ready-to-use pharma grade polyvinylpyrrolidone (PVP) solution containing HEPES buffered Human Tubal Fluid (HTF) mediu
04260650071836 - V-HYADASE 2023-07-24 V-HYADASE is a ready-to-use media for the denudation of oocytes prior to the intracytoplasmic sperm injection (ICSI). It contain
04260650071805 - V-SPERM WASH2023-03-08 V-SPERM WASH is an assisted reproduction medium intended for washing ofspermatozoa, the isolation of motile viable sperm by swim
04260531792249 - V-CENTERWELL-602022-12-01 IVF Labware are ready-to-use plastic disposables.
04260531792270 - V-CULTUREDISH-602022-12-01 IVF Labware are ready-to-use plastic disposables.
04260531792294 - V-CULTUREDISH-902022-12-01 IVF Labware are ready-to-use plastic disposables.

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