AccessGUDID - DEVICE: AQC (00860010518182)

GUDID

Device Identifier (DI) Information

Brand Name: AQC
Version or Model: AQC305
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AQC305
Company Name: Fertility Solutions, Inc.

Primary DI Number: 00860010518182
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 794781583 *Terms of Use

Device Description: Sperm Morphology Virtumorph® Quality Control - 1 fifty cell Virtumorph® printed virtual semen morphology smear and 1 Pap stained and coverslipped glass sperm morphology smear, 2 levels - a high and a low value. https://www.fertilitysolutions.com/product-category/sperm-morphology-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?
67049	Sperm morphology/viability control IVD	A prepared slide with a fixed semen smear, or a high-resolution colour printed image of stained or unstained normal sperm, intended to be used as reference material in the analysis of a semen specimen, to determine sperm morphology and/or viability. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LJG	Quality Control Slides

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
Special Storage Condition, Specify: Store in a dark, dry place at 20-25 C

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a5cba994-831a-490a-a2b1-122918aaf7ca
Public Version Date: April 23, 2024
Public Version Number: 1
DI Record Publish Date: April 15, 2024