FDA.report

Oocyte Flushing & Retrieval Medium

Primary DI
06976438300064
Brand
Oocyte Flushing & Retrieval Medium
Company
Gimbo Medical Technology Shenzhen Co., Ltd.
Model
ORRM500
Device description
Oocyte Flushing & Retrieval Medium, 500mL
Published
2024-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MQLMedia, Reproductive

Product Code Classifications

CodeDeviceSpecialtyClass
MQLMedia, ReproductiveObstetrics/Gynecology2

Premarket Submissions

SubmissionSupplement
K234023000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K234023000Oocyte Flushing & Retrieval Medium; Gamete BufferGimbo Medical Technology Shenzhen Co., Ltd.2024-05-10MQL

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06976438300064PrimaryGS10

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
722458269
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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
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
06976438300194Giftlife™ Blastocyst MediumBM602024-06-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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00859500005325FemSperm No AnalysisFEMASYS INC.MQL2026-02-06
00859500005356FemSperm No AnalysisFEMASYS INC.MQL2026-02-06
00888937028331ORIGIO Sequential BlastCoopersurgical, Inc.MQL2026-02-05
00888937028348ORIGIO Sequential BlastCoopersurgical, Inc.MQL2026-02-05
00888937028355ORIGIO Sequential BlastCoopersurgical, Inc.MQL2026-02-05
00888937028386ORIGIO Sequential CleavCoopersurgical, Inc.MQL2026-02-05
00888937028393ORIGIO Sequential CleavCoopersurgical, Inc.MQL2026-02-05
00888937028409ORIGIO Sequential CleavCoopersurgical, Inc.MQL2026-02-05
00888937028416ORIGIO Sequential CleavCoopersurgical, Inc.MQL2026-02-05
00888937028430ORIGIO Sequential FertCoopersurgical, Inc.MQL2026-02-05
00888937028447ORIGIO Sequential FertCoopersurgical, Inc.MQL2026-02-05
00888937028454ORIGIO Sequential FertCoopersurgical, Inc.MQL2026-02-05
00888937028461ORIGIO Sequential FertCoopersurgical, Inc.MQL2026-02-05
00888937028607SynVitro FlushCoopersurgical, Inc.MQL2026-02-05
00888937028959Origio HandlingCoopersurgical, Inc.MQL2026-02-05
00888937028966Origio HandlingCoopersurgical, Inc.MQL2026-02-05
00888937028973Origio HandlingCoopersurgical, Inc.MQL2026-02-05
00888937028980Origio HandlingCoopersurgical, Inc.MQL2026-02-05
00888937029116SAGE 1-StepCoopersurgical, Inc.MQL2026-02-05
00888937029123SAGE 1-StepCoopersurgical, Inc.MQL2026-02-05
60888937029330ORIGIO Sperm WashCoopersurgical, Inc.MQL2026-02-05
60888937029361ORIGIO Gradient 100Coopersurgical, Inc.MQL2026-02-05
00888937029383ORIGIO Gradient 90Coopersurgical, Inc.MQL2026-02-05
00888937833041SAGE 1-StepCoopersurgical, Inc.MQL2026-02-05
00888937027921SynVitro HyadaseCoopersurgical, Inc.MQL2026-02-05
00888937029970ICSI CumulaseCoopersurgical, Inc.MQL2026-02-05
60888937028203IVM SystemCoopersurgical, Inc.MQL2026-02-05
60888937029194MC Vitrification CoolingCoopersurgical, Inc.MQL2026-02-05
60888937029200MC Vitrification WarmingCoopersurgical, Inc.MQL2026-02-05