FDA.reportPublic FDA data

Giftlife™ Single Step Medium

Primary DI
06976438300224
Brand
Giftlife™ Single Step Medium
Company
Gimbo Medical Technology Shenzhen Co., Ltd.
Model
SSM60
Device description
Giftlife™ Single Step Medium, 60mL
Published
2024-06-25
Public version status
New
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
K240149000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240149000Giftlife™ Fertilization Medium; Giftlife™ Cleavage Medium; Giftlife™ Blastocyst Medium; Giftlife™ Single Step MediumGimbo Medical Technology Shenzhen Co., Ltd.2024-06-13MQL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06976438300224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06976438300224069764383002246976438300224

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
722458269
Device count
1
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
06976438300279Sperm Freezing MediumSFM102025-01-20
06976438300385Single Step Medium PlusEM302025-01-20
06976438300392Single Step Medium PlusEM602025-01-20
06976438300408Sperm Freezing MediumSFM302025-01-20
06976438300033Oocyte Flushing & Retrieval MediumORRM602024-06-25
06976438300040Oocyte Flushing & Retrieval MediumORRM1252024-06-25
06976438300057Oocyte Flushing & Retrieval MediumORRM2502024-06-25
06976438300064Oocyte Flushing & Retrieval MediumORRM5002024-06-25
06976438300071Gamete BufferGB602024-06-25
06976438300088Gamete BufferGB1252024-06-25
06976438300095Gamete BufferGB2502024-06-25
06976438300101Gamete BufferGB5002024-06-25
06976438300118Giftlife™ Fertilization MediumFM102024-06-25
06976438300125Giftlife™ Fertilization MediumFM302024-06-25
06976438300132Giftlife™ Fertilization MediumFM602024-06-25
06976438300149Giftlife™ Cleavage MediumCM102024-06-25
06976438300156Giftlife™ Cleavage MediumCM302024-06-25
06976438300163Giftlife™ Cleavage MediumCM602024-06-25
06976438300170Giftlife™ Blastocyst MediumBM102024-06-25
06976438300187Giftlife™ Blastocyst MediumBM302024-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540161790127CaseBio®CaseBioscience IncMQL2026-10-31
07540161790134CaseBio®CaseBioscience IncMQL2026-10-31
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