FDA.reportPublic FDA data

Hypure Oil Heavy 50mL

Primary DI
14582231460332
Brand
Hypure Oil Heavy 50mL
Company
KITAZATO CORPORATION
Model
MOHV-50
Published
2016-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQLMEDIA, REPRODUCTIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQLMedia, ReproductiveObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14582231460332PackageGS11In Commercial Distribution
04582231460335PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1458223146033214582231460332
04582231460335045822314603354582231460335

GMDN Terms#

Term, Definition table
TermDefinition
IVF medium kitA collection of solutions used to provide 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 solutions typically contain various combinations of salts, carbohydrates, amino acids, enzymes, hormones, albumin, vitamins, and/or drugs (e.g., antibiotics). Some included solutions may indirectly support the IVF process. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature8 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
711091157
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00888937028508LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028515LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028522LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028539LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028546LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028614LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028621LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028638LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028645LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028652LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028669LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028676LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028683LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028690LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028706LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028713LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028935LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937028942LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029017LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029024LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029031LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029130LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029147LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029154LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029161LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029178LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00888937029185LifeGlobal® MediaCoopersurgical, Inc.MQL2026-05-11
00860012751631Warming Solution SetEXPERIMENTAL CULTURE MEDIA PRODUCTIONS AND CONSIGNMENT LLCMQL2026-04-03
00860012751648Vitrification Solution SetEXPERIMENTAL CULTURE MEDIA PRODUCTIONS AND CONSIGNMENT LLCMQL2026-04-03
00860012751655Warming Solution SetEXPERIMENTAL CULTURE MEDIA PRODUCTIONS AND CONSIGNMENT LLCMQL2026-04-03