Prevahex

Basic Information

• Brand Name: Prevahex
• Primary DI: B5591488BOX1
• Version / Model: 1488BOX
• Catalog Number: 1488BOX
• Company Name: Entrotech Life Sciences, LLC
• Labeler DUNS: 080030899
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2019-12-16
• Public Version: 3
• Public Version Date: 2023-09-26
• Public Version Status: Update
• Public Device Record Key: 3e28ae6f-a089-407a-ac03-c1157d2531b3

Device Description

Prevahex Antimicrobial Transparent Film Dressings, I.V. Securement, 2.8 IN Diameter, 400 Dressings/Case, 1488CH

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
58302	Antimicrobial synthetic polymer semi-permeable film dressing, adhesive	A sterile, transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue to provide protection (e.g., from dirt, water) and/or promote healing, and that contains an antimicrobial agent. It is a thin, clear film made of synthetic polymer with a pressure-sensitive adhesive on one side that may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions, ulcers, burns, lacerations, abrasions, device insertion sites, and donor/graft sites. It may also be used to secure to skin other devices (e.g., catheters, drains, leads, ports). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B5591488BOX1	HIBCC
Unit of Use	B5591488CH0	HIBCC
Package	B5591488CASE3	HIBCC	CASE	4	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K140389	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 75 Degrees Celsius