FDA.reportPublic FDA data

SPERM FREEZING MEDIUM - SpermFreeze

Primary DI
00859268006237
Brand
SPERM FREEZING MEDIUM - SpermFreeze
Company
INVITROCARE, INCORPORATED
Model
2230
Catalog number
2230
Device description
SPERM FREEZING MEDIUM - SpermFreeze is a HEPES-buffered freezing medium for use with human sperm. It contains 0.4% human serum albumin. SpermFreeze is intended to be used as a cryopreservation medium for human sperm.
Published
2016-09-24
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
K053494000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053494000OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZEFertipro NV2006-03-23MQL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859268006237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859268006237008592680062378592680062370859268006237

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
190094230
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859268006329SPERM FREEZING MEDIUM - SpermFreeze2230-502230-502026-01-15
00859268006312PVP - Polyvinylpyrrolidone2210-502025-10-02
00859268006305HYALURONIDSE2212-102212-102022-07-29
00859268006275HTF HEPES2002-L2002-L2021-11-04
00859268006282SPERM WASH MEDIUM2005-L2005-L2021-11-04
10859268006043SPERM WASH MEDIUM200320032016-09-24
10859268006128HUMAN SERUM ALBUMIN210121012016-09-24
10859268006241SPERMCARE / SPERM WASH - Gradient System222422242016-09-24
10859268006258SPERM WASH MEDIUM for Swim-Up262026202016-09-24
00859268006008HTF culture medium200120012016-09-24
00859268006015HTF HEPES200220022016-09-24
00859268006022HTF HEPES2002-52002-52016-09-24
00859268006039SPERM WASH MEDIUM2003-12003-12016-09-24
00859268006053SPERM WASH MEDIUM200520052016-09-24
00859268006060SPERM WASH MEDIUM2005-52005-52016-09-24
00859268006077SPERM WASH MEDIUM2003-K22003-K22016-09-24
00859268006084SPERM WASH MEDIUM2003-K752003-K752016-09-24
00859268006091IVC-TWO2008-V2008-V2016-09-24
00859268006107IVC-THREE Blastocyst Medium2007-V2007-V2016-09-24
00859268006114HUMAN SERUM ALBUMIN2101-12101-12016-09-24

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