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

Hypure Oil Heavy

Name: Hypure Oil Heavy
Brand: Hypure Oil Heavy

6 catalogue numbers from Hypure Oil Heavy, listed by Kitazato Corporation, Japan, under Media, Reproductive, Exempt. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

6catalogue 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 Hypure Oil Heavy
Listed by	Kitazato Corporation, Japan
FDA product code	QKI
Device type	Media, Reproductive, Exempt
Device class	Class 2
Regulation	21 CFR 884.6180
Establishment	Complaint-file establishment, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2024-01-10

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Label carries	lot or batch number, expiry date, serial number
Storage	Storage environment temperature 15 to 25 °C
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Hypure Oil Heavy
Catalogue number	Size	Status
Hypure Oil Heavy		In distribution
Hypure Oil Heavy		In distribution
Hypure Oil Heavy		In distribution
Hypure Oil Heavy		In distribution
Hypure Oil Heavy		In distribution
Hypure Oil Heavy		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
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
ARTSMedia High Viscosity Oil (AM-HV Oil)	AMS Denmark ApS	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.