IV Clear 4x4 with crosshair

Basic Information

• Brand Name: IV Clear 4x4 with crosshair
• Primary DI: 00825439010136
• Version / Model: TWBD1011
• Company Name: Covalon Technologies Ltd
• Labeler DUNS: 206936101
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-30
• Public Version: 1
• Public Version Date: 2022-12-08
• Public Version Status: New
• Public Device Record Key: 6313c7f7-3b0d-4d0d-a9a3-3d52055d4ad0

Device Description

Antimicrobial clear silicone adhesive dressing

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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
Package	00825439010143	GS1	Carton	25	In Commercial Distribution
Primary	00825439010136	GS1
Package	10825439010140	GS1	Shipper	4	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K112549	000

Device Sizes

Type	Value	Unit	Text
Length	4	Centimeter
Width	4	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius