AccessGUDID - DEVICE: Fertility Solutions (00860010518120)

GUDID

Device Identifier (DI) Information

Brand Name: Fertility Solutions
Version or Model: FSI111
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FSI111
Company Name: Fertility Solutions, Inc.

Primary DI Number: 00860010518120
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 794781583 *Terms of Use

Device Description: 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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NRF	Material, Quality Control, Semen Analysis

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 300 microliters per vial

Device Record Status

Public Device Record Key: c10ba5e9-993b-46d3-a523-78f8053662f6
Public Version Date: November 07, 2023
Public Version Number: 1
DI Record Publish Date: October 30, 2023