What is FDA product code QKI?

This product code is the class II exempt counterpart of MQL, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.

Obstetrics & Gynecology › MiscellaneousMedia, Reproductive, Exempt

ARTSMedia High Viscosity Oil (AM-HV Oil)

Name: ARTSMedia High Viscosity Oil (AM-HV Oil)
Brand: ARTSMedia High Viscosity Oil (AM-HV Oil)

"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…

Registry build 21.09.26

“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. “

2manufacturers in China registered for this device type

2catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (1), Zhejiang (1).

Chinese manufacturers registered for FDA product code QKI
Manufacturer	City	Province	Registered as	Device types
Shenzhen VitaVitro Biotech Co., Ltd.	Shenzhen	Guangdong	Manufacturer	7
Arsci Biomedical Inc.	Jiaxing	Zhejiang	Manufacturer	2

Record

Regulatory record for ARTSMedia High Viscosity Oil (AM-HV Oil)
Listed by	AMS Denmark ApS, Denmark
FDA product code	QKI
Device type	Media, Reproductive, Exempt
Device class	Class 2
Regulation	21 CFR 884.6180
Establishment	Repacker / relabeller, Manufacturer
Premarket notification	Exempt
Record published	2024-01-22
Record revised	2026-06-24 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for ARTSMedia High Viscosity Oil (AM-HV Oil)
Catalogue number	Size	Status
50 ml		In distribution
100 ml		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Hypure Oil Heavy	Kitazato Corporation	6
FertiCult High Viscosity Oil	Fertipro NV	6
Hypure Oil Light	Kitazato Corporation	6
V-OIL	Vitromed GmbH	4
CaseBioscience®	Casebioscience, Inc.	3
VitaVitro	Shenzhen VitaVitro Biotech Co., Ltd.	3
Ovoil	Vitrolife Sweden AB	2
Ovoil Heavy	Vitrolife Sweden AB	1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.