FDA.reportPublic FDA data

QUINN'S Sperm Washing Kit

Primary DI
20888937818202
Brand
QUINN'S Sperm Washing Kit
Company
Origio A/S
Model
ART-1012
Device description
QUINN'S Sperm Washing Kit. Without Antibiotics. 12x12 ml
Published
2017-03-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
20888937818202PrimaryGS10
00888937818185Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088893781820220888937818202
00888937818185008889378181858889378181850888937818185

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.

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
12
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
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