Fertility Solutions

Basic Information

• Brand Name: Fertility Solutions
• Primary DI: 00860010518199
• Version / Model: SA400
• Catalog Number: SA400
• Company Name: Fertility Solutions, Inc.
• Labeler DUNS: 794781583
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2023-10-30
• Public Version: 1
• Public Version Date: 2023-11-07
• Public Version Status: New
• Public Device Record Key: 2ccf14c8-cdbe-41f2-8c15-29483ddccc0f

Device Description

Spermocytometer® sperm counting chambers. Box of 25 disposable slides each containing 2 single use counting chambers. 20 micron deep fixed coverslip glass chambers. Requires the use of an eyepiece reticle. https://www.fertilitysolutions.com/product-category/spermocytometer

Device Characteristics

• Single Use: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GHO	Hemocytometer	Hematology	864.6160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43673	Microscope counting chamber IVD	A counting chamber intended to be used for the microscopic enumeration of cells, cellular particles, or other biological components present in clinical laboratory specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	86001051819986	GS1
Primary	00860010518199	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Depth	20	Micrometer