ARTSMedia High Viscosity Oil (AM-HV Oil)

Primary DI
05745000591022
Brand
ARTSMedia High Viscosity Oil (AM-HV Oil)
Company
Artsmedia Denmark ApS
Model
50 ml
Catalog number
506050
Device description
"""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. """
Published
2024-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
QKIMedia, Reproductive, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKIMedia, Reproductive, ExemptObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05745000591022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05745000591022057450005910225745000591022

GMDN Terms#

Term, Definition table
TermDefinition
IVF mediumA solution that provides a physiological environment for the retrieval, culture, maintenance, transfer, and/or storage of human sperm, harvested oocytes (eggs), and/or resulting embryos associated with the method of in vitro fertilization (IVF). The solution typically contains various combinations of salts, carbohydrates, amino acids, enzymes, hormones, albumin, vitamins, and/or drugs (e.g., antibiotics). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
306267547
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05745000591107ARTSMedia Semen Wash Medium (AM Semen Wash)20 ml5050202025-01-31
05745000591114ARTSMedia Semen Wash Medium (AM Semen Wash)50 ml5050502025-01-31
05745000591121ARTSMedia Semen Wash Medium (AM Semen Wash)100 ml5051002025-01-31
05745000591138ARTSMedia Oocyte Aspiration Medium (AM Oocyte Aspiration)20 ml5020202025-01-31
05745000591145ARTSMedia Oocyte Aspiration Medium (AM Oocyte Aspiration)50 ml5020502025-01-31
05745000591152ARTSMedia Oocyte Aspiration Medium (AM Oocyte Aspiration)100 ml5021002025-01-31
05745000591046ARTSMedia Sperm Gradient Medium 45 % (AM-SDG Medium 45 %)20 ml5030202024-02-26
05745000591053ARTSMedia Sperm Gradient Medium 45 % (AM-SDG Medium 45 %)50 ml5030502024-02-26
05745000591060ARTSMedia Sperm Gradient Medium 45 % (AM-SDG Medium 45 %)100 ml5031002024-02-26
05745000591077ARTSMedia Sperm Gradient Medium 90 % (AM-SDG Medium 90 %)20 ml5040202024-02-26
05745000591084ARTSMedia Sperm Gradient Medium 90 % (AM-SDG Medium 90 %)50 ml5040502024-02-26
05745000591091ARTSMedia Sperm Gradient Medium 90 % (AM-SDG Medium 90 %)100 ml5041002024-02-26
05745000591039ARTSMedia High Viscosity Oil (AM-HV Oil)100 ml5061002024-01-22
05745000591015ARTSMedia In Vitro Culture Medium10 mL5010102023-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07540161790035CaseBioscience®CaseBioscience IncQKI2024-01-31
07540161790042CaseBioscience®CaseBioscience IncQKI2024-01-31
05745000591039ARTSMedia High Viscosity Oil (AM-HV Oil)Artsmedia Denmark ApSQKI2024-01-22
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