Fertility Solutions FSI111

GUDID 00860010518120

Post Vasectomy Quality Control containing stabilized human sperm, 2 vials of 300 µL each, 2 levels - positive and negative. https://www.fertilitysolutions.com/product-category/post-vasectomy-quality-control

Fertility Solutions, Inc.

Sperm concentration indicator IVD, control

• Primary Device ID: 00860010518120
• NIH Device Record Key: c10ba5e9-993b-46d3-a523-78f8053662f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fertility Solutions
• Version Model Number: FSI111
• Catalog Number: FSI111
• 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	00860010518120 [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

On-Brand Devices [Fertility Solutions]

• 86001051819986: Spermocytometer® sperm counting chambers. Box of 25 disposable slides each containing 2 single
• 08600105181370: Post Vasectomy Quality Control containing stabilized human sperm, 2 vials of 150 µL each, 2 le
• 08600105181202: Post Vasectomy Quality Control containing stabilized human sperm, 2 vials of 300 µL each, 2 le
• 08600105181134: Sperm Count Quality Control containing stabilized human sperm, 2 vials of 150 µL each, 2 level
• 08600105181066: Sperm Count Quality Control containing stabilized human sperm, 2 vials of 300 µL each, 2 level
• 00860010518137: Post Vasectomy Quality Control containing stabilized human sperm, 2 vials of 150 µL each, 2 le
• 00860010518120: Post Vasectomy Quality Control containing stabilized human sperm, 2 vials of 300 µL each, 2 le
• 00860010518113: Sperm Count Quality Control containing stabilized human sperm, 2 vials of 150 µL each, 2 level
• 00860010518106: Sperm Count Quality Control containing stabilized human sperm, 2 vials of 300 µL each, 2 level