FDA.reportPublic FDA data

FemSperm Pack Analysis

Primary DI
00859500005318
Brand
FemSperm Pack Analysis
Company
FEMASYS INC.
Model
FSP-400
Catalog number
05444
Device description
FemSperm Convenience Pack With Analysis (5-Pack)
Published
2026-02-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQLMedia, Reproductive
POVSemen Analysis Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQLMedia, ReproductiveObstetrics/Gynecology2
POVSemen Analysis DeviceHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859500005318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859500005318008595000053188595000053180859500005318

GMDN Terms#

Term, Definition table
TermDefinition
Spermatozoa/semen analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro examination of a semen specimen to assess volume, spermatozoa concentration, motility and/or morphological characteristics.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
147590330
Device count
1
Kit
true
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
00859500005288FemSperm Analyzer FSP-500054472026-02-06
00859500005325FemSperm No AnalysisFSP-401054452026-02-06
00859500005349FemSperm Pack AnalysisFSP-402055492026-02-06
00859500005356FemSperm No AnalysisFSP-403055502026-02-06
20859500005008FemVueFSA-2002026-01-06
30859500005005FemVueFSA-2002026-01-06
20859500005169StopLockSLK-100043912025-05-02
10859500005162StopLockSLK-100043902025-05-02
00859500005165StopLockSLK-100043912025-05-02
30859500005166StopLockSLK-100043922025-05-02
00859500005097FemChec FCD-2502024-09-16
00859500005080FemCathCBC-150041942023-06-06
00859500005127VariLockVL-1001041782024-03-13
00859500005103FemaSeedFDI-2002024-01-22
20859500005107FemaSeedFDI-2002023-11-28
30859500005104FemaSeedFDI-2002023-11-29
10859500005100FemaSeedFDI-2002023-11-28
10859500005018FemaSeedFDI-2002023-11-28
00859500005011FemaSeedFDI-2002023-11-28
00859500005042FemCathCBC-1501031972023-06-06

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
14719874742680LensHooke Semen Quality AnalyzerBONRAYBIO CO., LTD.POV2026-04-23
00860012751631Warming Solution SetEXPERIMENTAL CULTURE MEDIA PRODUCTIONS AND CONSIGNMENT LLCMQL2026-04-03
00860012751648Vitrification Solution SetEXPERIMENTAL CULTURE MEDIA PRODUCTIONS AND CONSIGNMENT LLCMQL2026-04-03