Fertility Solutions FSI103

GUDID 00860010518106

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

Fertility Solutions, Inc.

Sperm concentration indicator IVD, control

• Primary Device ID: 00860010518106
• NIH Device Record Key: 79db0fee-eb31-4101-bcb4-386ef7c6a108
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fertility Solutions
• Version Model Number: FSI103
• Catalog Number: FSI103
• Company DUNS: 794781583
• Company Name: Fertility Solutions, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com
• Phone: 216-491-0030
• Email: businessmgr@fertilitysolutions.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010518106 [Primary]

FDA Product Code

• NRF: Material, Quality Control, Semen Analysis

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-07
• Device Publish Date: 2023-10-30

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• 00860010518106: Sperm Count Quality Control containing stabilized human sperm, 2 vials of 300 µL each, 2 level