Enhance Sperm Wash w/ Gentamicin

Basic Information

• Brand Name: Enhance Sperm Wash w/ Gentamicin
• Primary DI: 00805360016865
• Version / Model: 15263
• Company Name: VITROLIFE INC.
• Labeler DUNS: 051915038
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-20
• Public Version: 3
• Public Version Date: 2020-04-29
• Public Version Status: Update
• Public Device Record Key: fac96540-5596-4a63-bfc4-4859f88f4765

Device Description

1-(500ml) Enhance Sperm Wash w/ Gentamicin

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQL	Media, Reproductive	Obstetrics/Gynecology	884.6180	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59858	Spermatozoa/semen motility medium supplement	A sterile supplemental solution intended to be added to the medium during semen preparation for use in assisted reproduction technique (ART) procedures so as to enhance semen fluidity and sperm motility. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00805360016865	GS1

Premarket Submissions

Submission Number	Supplement Number
K023717	000

Device Sizes

Type	Value	Unit	Text
Total Volume	100	Milliliter