Fertility Solutions

Basic Information

• Brand Name: Fertility Solutions
• Primary DI: 08600105181066
• Version / Model: FSI103
• Catalog Number: FSI103
• Company Name: Fertility Solutions, Inc.
• Labeler DUNS: 794781583
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-15
• Public Version: 2
• Public Version Date: 2023-10-31
• Public Version Status: Update
• Public Device Record Key: 00920ff0-dbc5-41fb-9ccc-99ac70e50877
• Distribution End Date: 2023-10-29

Device Description

Sperm Count Quality Control containing stabilized human sperm, 2 vials of 300 µL each, 2 levels - high and low concentrations. https://www.fertilitysolutions.com/product-category/sperm-count-quality-control

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NRF	Material, Quality Control, Semen Analysis	Hematology	864.8625	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61075	Sperm concentration indicator IVD, control	A material that is used to verify the performance of an assay intended to be used to indicate the concentration of sperm in a semen specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08600105181066	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			300 microliters per vial

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius