FDA.reportPublic FDA data

VitaVitro

Primary DI
06971982050014
Brand
VitaVitro
Company
SHENZHEN VITAVITRO BIOTECH CO.,LTD.
Model
LD-1.0
Catalog number
V002001, V002002
Published
2018-12-05
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
MQLMedia, Reproductive

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180073000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180073000Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw SetShenzhen Vitavitro Bio-Tech Co., Ltd.2018-08-29MQL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971982050014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971982050014069719820500146971982050014

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction vitrification kitA collection of reusable/consumable devices used for the vitrification (cryopreservation) and recovery of biological specimens (e.g., eggs, embryos) in assisted reproduction procedures. It is typically used by embryologists/medical scientists to perform ultra-rapid cooling of a specimen without immersion/contact of the specimen with liquid nitrogen (LN2), and enables subsequent warming to recover the specimen. It typically consists of a highly-conductive metal block with surfaces/slots used for the vitrification process, a cryobath for the LN2 in which the block is placed, plastic carriers to hold and store the specimen, and pipetting devices.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544504573
Device count
1
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
06971982050397VitaVitroCulture Oil, Oil-1.0, 60mlV0090602022-12-22
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

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