FDA.reportPublic FDA data

ARTSMedia Sperm Gradient Medium 90 % (AM-SDG Medium 90 %)

Primary DI
05745000591077
Brand
ARTSMedia Sperm Gradient Medium 90 % (AM-SDG Medium 90 %)
Company
Artsmedia Denmark ApS
Model
20 ml
Catalog number
504020
Device description
Intended for human sperm separation by density gradient centrifugation.
Published
2024-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
05745000591077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05745000591077057450005910775745000591077

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
306267547
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05745000591107ARTSMedia Semen Wash Medium (AM Semen Wash)20 ml5050202025-01-31
05745000591114ARTSMedia Semen Wash Medium (AM Semen Wash)50 ml5050502025-01-31
05745000591121ARTSMedia Semen Wash Medium (AM Semen Wash)100 ml5051002025-01-31
05745000591138ARTSMedia Oocyte Aspiration Medium (AM Oocyte Aspiration)20 ml5020202025-01-31
05745000591145ARTSMedia Oocyte Aspiration Medium (AM Oocyte Aspiration)50 ml5020502025-01-31
05745000591152ARTSMedia Oocyte Aspiration Medium (AM Oocyte Aspiration)100 ml5021002025-01-31
05745000591046ARTSMedia Sperm Gradient Medium 45 % (AM-SDG Medium 45 %)20 ml5030202024-02-26
05745000591053ARTSMedia Sperm Gradient Medium 45 % (AM-SDG Medium 45 %)50 ml5030502024-02-26
05745000591060ARTSMedia Sperm Gradient Medium 45 % (AM-SDG Medium 45 %)100 ml5031002024-02-26
05745000591084ARTSMedia Sperm Gradient Medium 90 % (AM-SDG Medium 90 %)50 ml5040502024-02-26
05745000591091ARTSMedia Sperm Gradient Medium 90 % (AM-SDG Medium 90 %)100 ml5041002024-02-26
05745000591022ARTSMedia High Viscosity Oil (AM-HV Oil)50 ml5060502024-01-22
05745000591039ARTSMedia High Viscosity Oil (AM-HV Oil)100 ml5061002024-01-22
05745000591015ARTSMedia In Vitro Culture Medium10 mL5010102023-04-28

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