Fertility Solutions FSI203
GUDID 08600105181134
Sperm Count Quality Control containing stabilized human sperm, 2 vials of 150 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 | 08600105181134 |
| NIH Device Record Key | c346bf7a-8bef-47f9-b6c7-8f11e16f6cae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fertility Solutions |
| Version Model Number | FSI203 |
| Catalog Number | FSI203 |
| 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
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 |
| 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 |
| 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 | 08600105181134 [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 | 2023-09-25 |
| Device Publish Date | 2023-09-15 |
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 |
Trademark Results [Fertility Solutions]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FERTILITY SOLUTIONS 85463145 4315593 Live/Registered |
Fertility Solutions, Inc. 2011-11-03 |
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