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 ID05745000591022
NIH Device Record Key921f6b12-8d48-44e8-975a-de9adb29ff4c
Commercial Distribution StatusIn Commercial Distribution
Brand NameARTSMedia High Viscosity Oil (AM-HV Oil)
Version Model Number50 ml
Catalog Number506050
Company DUNS306267547
Company NameArtsmedia Denmark ApS
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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
GS105745000591022 [Primary]

FDA Product Code

QKIMedia, Reproductive, Exempt

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-30
Device Publish Date2024-01-22

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

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