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

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• 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

• 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.
• 05745000591060 - ARTSMedia Sperm Gradient Medium 45 % (AM-SDG Medium 45 %): 2024-03-05 Intended for human sperm separation by density gradient centrifugation.
• 05745000591077 - ARTSMedia Sperm Gradient Medium 90 % (AM-SDG Medium 90 %): 2024-03-05 Intended for human sperm separation by density gradient centrifugation.
• 05745000591084 - ARTSMedia Sperm Gradient Medium 90 % (AM-SDG Medium 90 %): 2024-03-05 Intended for human sperm separation by density gradient centrifugation.
• 05745000591091 - ARTSMedia Sperm Gradient Medium 90 % (AM-SDG Medium 90 %): 2024-03-05 Intended for human sperm separation by density gradient centrifugation.
• 05745000591022 - ARTSMedia High Viscosity Oil (AM-HV Oil): 2024-01-30 "AM-HV Oil is a high viscosity mineral oil (d=0.86-0.88g/ml) pre-washed with ultra pure water for use in In Vitro Fertilization
• 05745000591039 - ARTSMedia High Viscosity Oil (AM-HV Oil): 2024-01-30 "AM-HV Oil is a high viscosity mineral oil (d=0.86-0.88g/ml) pre-washed with ultra pure water for use in In Vitro Fertilization