FDA.reportPublic FDA data

HYASE-10X

Primary DI
17350025910762
Brand
HYASE-10X
Company
Vitrolife Sweden AB
Model
10176
Published
2021-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000627000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000627000SCANDINAVIAN IVF SCIENCES AB, HYBASE-1Vitrolife AB/Scandinavian Ivf Sciences AB2000-06-13MQL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17350025910762PrimaryGS10
07350025910765Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1735002591076217350025910762
07350025910765073500259107657350025910765

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.

Regulatory Flags#

DUNS number
631805488
Device count
5
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
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
07350025910017ASP101002016-09-13

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