ARTSMedia In Vitro Culture Medium

GUDID 05745000591015

ARTSMedia In Vitro Culture Medium is a culture medium intended for in vitro fertilization and in vitro culture of human gametes and embryos from fertilization until the blastocyst stage of development (day 5). The medium can also be used for embryo transfer.

Artsmedia Denmark ApS

IVF medium

• Primary Device ID: 05745000591015
• NIH Device Record Key: 75dc3a24-3dab-4adb-8b35-8b2ec0c896c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARTSMedia In Vitro Culture Medium
• Version Model Number: 10 mL
• Company DUNS: 306267547
• Company Name: Artsmedia Denmark ApS
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05745000591015 [Primary]

FDA Product Code

• MQL: Media, Reproductive

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-08
• Device Publish Date: 2023-04-28

Devices Manufactured by Artsmedia Denmark ApS

• 05745000591107 - ARTSMedia Semen Wash Medium (AM Semen Wash): 2025-02-10 Intended for washing of sperm and for sperm swim-up procedures. The medium can also be used for IUI (Intra Uterine Insemination)
• 05745000591114 - ARTSMedia Semen Wash Medium (AM Semen Wash): 2025-02-10 Intended for washing of sperm and for sperm swim-up procedures. The medium can also be used for IUI (Intra Uterine Insemination)
• 05745000591121 - ARTSMedia Semen Wash Medium (AM Semen Wash): 2025-02-10 Intended for washing of sperm and for sperm swim-up procedures. The medium can also be used for IUI (Intra Uterine Insemination)
• 05745000591138 - ARTSMedia Oocyte Aspiration Medium (AM Oocyte Aspiration): 2025-02-10 Intended for retrieval of human oocytes by follicular aspiration or flushing. The medium can also be used for washing of oocytes
• 05745000591145 - ARTSMedia Oocyte Aspiration Medium (AM Oocyte Aspiration): 2025-02-10 Intended for retrieval of human oocytes by follicular aspiration or flushing. The medium can also be used for washing of oocytes
• 05745000591152 - ARTSMedia Oocyte Aspiration Medium (AM Oocyte Aspiration): 2025-02-10 Intended for retrieval of human oocytes by follicular aspiration or flushing. The medium can also be used for washing of oocytes
• 05745000591046 - ARTSMedia Sperm Gradient Medium 45 % (AM-SDG Medium 45 %): 2024-03-05 Intended for human sperm separation by density gradient centrifugation.
• 05745000591053 - ARTSMedia Sperm Gradient Medium 45 % (AM-SDG Medium 45 %): 2024-03-05 Intended for human sperm separation by density gradient centrifugation.