Enhance Water for Tissue Culture

Basic Information

• Brand Name: Enhance Water for Tissue Culture
• Primary DI: 00805360018494
• Version / Model: 15522
• Company Name: VITROLIFE INC.
• Labeler DUNS: 051915038
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-23
• Public Version: 6
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: fa9612a7-ffbd-475c-9ebe-2c4ebf099001
• Distribution End Date: 2020-04-28

Device Description

Enhance Water for Tissue Culture, 1.5 Liter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
MTW	System, Water, Reproduction, Assisted, And Purification	Obstetrics/Gynecology	884.6170	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44643	Intravenous/irrigation solution storage container, single-use	An empty glass or plastic receptacle intended for the safe storage and easy handling of solutions (e.g., sterile distilled water or saline) that are used during intravenous (IV) and/or irrigation procedures; however, it is neither intended to be connected to an IV administration set nor to irrigation equipment. It is produced in a variety of sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00805360018494	GS1

Premarket Submissions

Submission Number	Supplement Number
K993140	000