FDA.reportPublic FDA data

OVOIL HEAVY

Primary DI
07350025910338
Brand
OVOIL HEAVY
Company
Vitrolife Sweden AB
Model
10208
Published
2026-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
07350025910338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350025910338073500259103387350025910338

Regulatory Flags#

DUNS number
631805488
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
07350025910314OVOIL HEAVY101742020-08-25
07350025914800RapidVit Oocyte101212019-12-14
07350025914817RapidWarm Oocyte101222019-12-14
17350025910274ICSI101112016-09-13
17350025914784SpermGrad101382016-09-13
17350025914791SpermGrad101392016-09-13

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