FDA.reportPublic FDA data

In Vitro Maturation Kit

Primary DI
60888937818491
Brand
In Vitro Maturation Kit
Company
Origio A/S
Model
ART-1600
Device description
In Vitro Maturation Kit
Published
2017-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQLMedia, Reproductive

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60888937818491PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
6088893781849160888937818491

GMDN Terms#

Term, Definition table
TermDefinition
IVF medium kitA collection of solutions used to provide 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 solutions typically contain various combinations of salts, carbohydrates, amino acids, enzymes, hormones, albumin, vitamins, and/or drugs (e.g., antibiotics). Some included solutions may indirectly support the IVF process. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
305424269
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
60888937027138SAGE Vitrification Warming Kit XLART-80342022-11-23
00888937833027SynVitro Hyadase15135001D2021-01-18
00888937819342CSC Freezing MediumART-80172016-07-28
00888937801491EmbryoAssist12130010D2016-09-15
00888937833058SAGE 1-Step77010003D2019-02-27
00888937833072SAGE 1-Step77020003D2019-02-27
20888937972348Transem Spherical TSET24SAS2017-07-16
20888937972355EchoGen Spherical TSET24SASEG2017-07-16
20888937972362Transem Spherical O 24 cmTSET24SASO2017-07-16
20888937972379EchoGen Spherical OTSET24SASOEG2017-07-16
20888937972799Transem Stylet 19 cm = 24 cm ETTSET19242018-05-15
20888937020391VitriGuard438220012018-10-03
20888937020414VitriGuard438420012018-10-03
20888937020421VitriGuard438520012018-10-03
20888937020438VitriGuard438620012018-10-03
20888937021466VitriGuard438250052018-10-03
20888937021473VitriGuard438450052018-10-03
20888937021480VitriGuard438550052018-10-03
20888937021497VitriGuard438650052018-10-03
00888937835458Origio Handling83100060D83102018-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
60888937029798ORIGIO Gradient 90 w/o Gentamicin Coopersurgical, Inc.MQL2026-03-12
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