ARTSMedia High Viscosity Oil (AM-HV Oil) 506050

GUDID 05745000591022

"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 (IVF), Intracytoplasmic Sperm Injection (ICSI) and assisted reproductive technologies (ART). The oil permits small volumes of medium to be used for fertilization and embryo culture / handling. The oil overlay prevents media evaporation, which would result in increased osmolarity, and to avoid fluctuations in the pH and the temperature. "

Artsmedia Denmark ApS

IVF medium

• Primary Device ID: 05745000591022
• NIH Device Record Key: 921f6b12-8d48-44e8-975a-de9adb29ff4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARTSMedia High Viscosity Oil (AM-HV Oil)
• Version Model Number: 50 ml
• Catalog Number: 506050
• Company DUNS: 306267547
• Company Name: Artsmedia Denmark ApS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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	05745000591022 [Primary]

FDA Product Code

• QKI: Media, Reproductive, Exempt

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: 2024-01-30
• Device Publish Date: 2024-01-22

On-Brand Devices [ARTSMedia High Viscosity Oil (AM-HV Oil)]

• 05745000591039: "AM-HV Oil is a high viscosity mineral oil (d=0.86-0.88g/ml) pre-washed with ultra pure water fo
• 05745000591022: "AM-HV Oil is a high viscosity mineral oil (d=0.86-0.88g/ml) pre-washed with ultra pure water fo