FDA.reportPublic FDA data

Hypure Oil Heavy

Primary DI
04582231467259
Brand
Hypure Oil Heavy
Company
KITAZATO CORPORATION
Model
Hypure Oil Heavy
Catalog number
96013
Device description
1 Packs
Published
2024-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
14582231467256PackageGS11In Commercial Distribution
04582231467259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1458223146725614582231467256
04582231467259045822314672594582231467259

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
711091157
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04573316385360KITAZATO VACUUM LINEAPL-F150611612026-03-13
04580745043785ET CATHETER RYDENET-C3025PMOS-G20ASRT2133752025-09-17
04580745043907ET CATHETER RYDENET-C3022PMOS-G17ASRT2133522025-09-17
04580745044232ET CATHETER RYDENET-C3022PMOS+G17ASRT2233522025-09-17
04580745044249ET CATHETER RYDENET-C3025PMOS+G20ASRT2233752025-09-17
04573316385353KITAZATO VACUUM LINEAPL-F120611602026-03-13
04573316385377KITAZATO VACUUM LINEAPL-F180611622026-03-13
04573316388538KITAZATO VACUUM LINEAPL-F240611642026-03-13
14573316385367KITAZATO VACUUM LINEAPL-F150611612026-03-13
04573316388910Kitazato Blastomere Biopsy MicropipetteMT-BPBM-20-30953482025-10-07
04573316388927Kitazato Blastomere Biopsy MicropipetteMT-BPBM-20-35953492025-10-07
14580745043782ET CATHETER RYDENET-C3025PMOS-G20ASRT2133752025-09-17
14580745043904ET CATHETER RYDENET-C3022PMOS-G17ASRT2133522025-09-17
14580745044239ET CATHETER RYDENET-C3022PMOS+G17ASRT2233522025-09-17
14580745044246ET CATHETER RYDENET-C3025PMOS+G20ASRT2233752025-09-17
14573316384773Ultra-Fast WarmVT602USUF-TSx4912572025-08-28
14573316385107Ultra-Fast VitriVT601USUF-ESx4912602025-08-28
14573316385114Ultra-Fast VitriVT601USUF-VSx4912612025-08-28
14573316385978Ultra-Fast VitriVT601USUF-ES4x4912662025-08-28
14573316385985Ultra-Fast VitriVT601USUF-VS4x4912672025-08-28

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
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
06971982050403VitaVitroSHENZHEN VITAVITRO BIOTECH CO.,LTD.QKI2022-12-22