FDA.reportPublic FDA data

VitaVitro

Primary DI
06971982050397
Brand
VitaVitro
Company
SHENZHEN VITAVITRO BIOTECH CO.,LTD.
Model
Culture Oil, Oil-1.0, 60ml
Catalog number
V009060
Published
2022-12-22
Public version status
Update
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
06971982050397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971982050397069719820503976971982050397

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
544504573
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971982050328VitaVitroET-A2024-08-26
06971982050335VitaVitroET-S2024-08-26
06971982050342VitaVitroET-SI2024-08-26
06971982051066VitaVitroET-I2024-08-26
06971982051073VitaVitroET-IH2024-08-26
06971982050403VitaVitroCulture Oil, Oil-1.0,125mlV009125 2022-12-22
06971982050410VitaVitroCulture Oil, Oil-1.0,500 mlV0095002022-12-22
06971982050489VitaVitroMicromanipulation Pipettes, ICSI Pipette2022-12-22
06971982050496VitaVitroMicromanipulation Pipettes, Holding Pipette2022-12-22
06971982050502VitaVitroMicromanipulation Pipettes, Biopsy Pipette2022-12-22
06971982050519VitaVitroMicromanipulation Pipettes, Denuding Pipette2022-12-21
06971982050298VitaVitroORNS-17G2024-12-06
06971982050304VitaVitroORNS-18G2024-12-06
06971982050311VitaVitroORND-17G2024-12-06
06971982050526VitaVitroCulture Dish 35 mm,10 sets/pack2022-12-21
06971982050533VitaVitroCulture Dish 60 mm,10 sets/pack2022-12-21
06971982050540VitaVitroCulture Dish 90 mm, 10 sets/pack2022-12-21
06971982050557VitaVitro Culture Dish 100mm, 10 sets/pack2022-12-21
06971982050564VitaVitro Culture Dish, Central Well Culture Dish, 1 sets/p2022-12-21
06971982050571VitaVitro Culture Dish, Central Well Culture Dish, 10 sets/2022-12-21

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