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 ID: 00859268006107
• NIH Device Record Key: d4e0deb2-4e23-43c5-b009-f7a06c001223
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IVC-THREE Blastocyst Medium
• Version Model Number: 2007-V
• Catalog Number: 2007-V
• Company DUNS: 190094230
• Company Name: INVITROCARE, INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859268006107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001113

FDA Product Code

• MQL: Media, Reproductive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by INVITROCARE, INCORPORATED

• 00859268006305 - HYALURONIDSE: 2022-08-08 InVitroCare's HYALURONIDASE reagent is composed of Bovine Testes Hyaluronidase (Sigma Catalog #H4272) dissolved in a combined so
• 00859268006275 - HTF HEPES: 2021-11-12 HTF HEPES is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures. It has been fo
• 00859268006282 - SPERM WASH MEDIUM: 2021-11-12 SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is intended for use in
• 00859268006008 - HTF culture medium: 2018-07-06 HTF culture medium is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures. HTF u
• 00859268006015 - HTF HEPES: 2018-07-06 HTF HEPES is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures.It has been for
• 00859268006022 - HTF HEPES: 2018-07-06 HTF HEPES is a synthetic, defined culture medium intended for use in assisted reproductive technology procedures.It has been for
• 00859268006039 - SPERM WASH MEDIUM: 2018-07-06 SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is intended for use in
• 00859268006053 - SPERM WASH MEDIUM: 2018-07-06 SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is intended for use in