FDA.reportPublic FDA data

OVOIL HEAVY

Primary DI
07350025910314
Brand
OVOIL HEAVY
Company
Vitrolife Sweden AB
Model
10174
Published
2020-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
07350025910314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350025910314073500259103147350025910314

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
631805488
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350025910307OVOIL100292016-09-13
07350025910901EmbryoGlue101902022-01-28
17350025911660Ultrasound Transmission Gel142032016-09-13
07350025911618Ultrasound Transducer Cover142212025-04-16
07350025911625Ultrasound Transducer Cover142202025-04-16
07350025911632Ultrasound Transducer Cover142192025-04-16
17350025911615Ultrasound Transducer Cover142212025-04-16
17350025911622Ultrasound Transducer Cover142202025-04-16
17350025911639Ultrasound Transducer Cover142192025-04-16
07350025914220RapidWarm Blast101202016-09-13
17350025910762HYASE-10X101762021-12-31
07350025910604Gx-IVF101712021-05-21
07350025910611Gx-TL101722021-05-21
07350025910628Gx-MOPS PLUS101732021-05-21
07350025914800RapidVit Oocyte101212019-12-14
07350025914817RapidWarm Oocyte101222019-12-14
17350025910274ICSI101112016-09-13
17350025914784SpermGrad101382016-09-13
17350025914791SpermGrad101392016-09-13
07350025910017ASP101002016-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540161790028CaseBioscience®CaseBioscience IncQKI2024-01-31
07540161790035CaseBioscience®CaseBioscience IncQKI2024-01-31
07540161790042CaseBioscience®CaseBioscience IncQKI2024-01-31
05745000591022ARTSMedia High Viscosity Oil (AM-HV Oil)Artsmedia Denmark ApSQKI2024-01-22
05745000591039ARTSMedia High Viscosity Oil (AM-HV Oil)Artsmedia Denmark ApSQKI2024-01-22
04582231461639Hypure Oil LightKITAZATO CORPORATIONQKI2024-01-10
04582231461646Hypure Oil HeavyKITAZATO CORPORATIONQKI2024-01-10
04582231461653Hypure Oil HeavyKITAZATO CORPORATIONQKI2024-01-10
04582231461660Hypure Oil HeavyKITAZATO CORPORATIONQKI2024-01-10
04582231467198Hypure Oil LightKITAZATO CORPORATIONQKI2024-01-10
04582231467204Hypure Oil LightKITAZATO CORPORATIONQKI2024-01-10
04582231467211Hypure Oil LightKITAZATO CORPORATIONQKI2024-01-10
04582231467228Hypure Oil LightKITAZATO CORPORATIONQKI2024-01-10
04582231467235Hypure Oil LightKITAZATO CORPORATIONQKI2024-01-10
04582231467242Hypure Oil HeavyKITAZATO CORPORATIONQKI2024-01-10
04582231467259Hypure Oil HeavyKITAZATO CORPORATIONQKI2024-01-10
04582231467266Hypure Oil HeavyKITAZATO CORPORATIONQKI2024-01-10
05411967000470FertiCult High Viscosity OilFertipro NVQKI2023-02-28
05411967000487FertiCult High Viscosity OilFertipro NVQKI2023-02-28
05411967000500FertiCult High Viscosity OilFertipro NVQKI2023-02-28
05411967001170FertiCult High Viscosity OilFertipro NVQKI2023-02-28
05411967001194FertiCult High Viscosity OilFertipro NVQKI2023-02-28
05411967001217FertiCult High Viscosity OilFertipro NVQKI2023-02-28
05411967001231FertiCult High Viscosity OilFertipro NVQKI2023-02-28
05411967001248FertiCult High Viscosity OilFertipro NVQKI2023-02-28
05411967001255FertiCult High Viscosity OilFertipro NVQKI2023-02-28
05411967001187FertiCult High Viscosity OilFertipro NVQKI2023-02-28
05411967001200FertiCult High Viscosity OilFertipro NVQKI2023-02-28
05411967001224FertiCult High Viscosity OilFertipro NVQKI2023-02-28
06971982050397VitaVitroSHENZHEN VITAVITRO BIOTECH CO.,LTD.QKI2022-12-22