CovaView™ IV 8.5x10.5 6038510

GUDID 00825439013571

Transparent IV Dressing

Covalon Technologies Ltd

Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive Synthetic polymer semi-permeable film dressing, adhesive

Primary Device ID	00825439013571
NIH Device Record Key	8618ffac-3b5e-4e34-8b13-a62d738f2a4e
Commercial Distribution Status	In Commercial Distribution
Brand Name	CovaView™ IV 8.5x10.5
Version Model Number	6038510
Catalog Number	6038510
Company DUNS	206936101
Company Name	Covalon Technologies Ltd
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	false
OTC Over-The-Counter	true

Device Dimensions

Length	8.5 Centimeter
Width	10.5 Centimeter
Length	8.5 Centimeter
Width	10.5 Centimeter
Length	8.5 Centimeter
Width	10.5 Centimeter
Length	8.5 Centimeter
Width	10.5 Centimeter
Length	8.5 Centimeter
Width	10.5 Centimeter
Length	8.5 Centimeter
Width	10.5 Centimeter
Length	8.5 Centimeter
Width	10.5 Centimeter
Length	8.5 Centimeter
Width	10.5 Centimeter
Length	8.5 Centimeter
Width	10.5 Centimeter
Length	8.5 Centimeter
Width	10.5 Centimeter
Length	8.5 Centimeter
Width	10.5 Centimeter
Length	8.5 Centimeter
Width	10.5 Centimeter
Length	8.5 Centimeter
Width	10.5 Centimeter
Length	8.5 Centimeter
Width	10.5 Centimeter
Length	8.5 Centimeter
Width	10.5 Centimeter
Length	8.5 Centimeter
Width	10.5 Centimeter
Length	8.5 Centimeter
Width	10.5 Centimeter
Length	8.5 Centimeter
Width	10.5 Centimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00825439013564 [Primary]
GS1	00825439013571 [Package] Contains: 00825439013564 Package: Carton [50 Units] In Commercial Distribution

FDA Product Code

KMK	Device, Intravascular Catheter Securement

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-07-20
Device Publish Date	2023-07-12

Devices Manufactured by Covalon Technologies Ltd

00825439011393 - CovaWound™ Silicone 10x10	2024-04-16 Self-Adherent Soft Silicone Foam Dressing with Border
00825439011416 - CovaWound™ Silicone 12.5x12.5	2024-04-16 Self-Adherent Soft Silicone Foam Dressing with Border
00825439011430 - CovaWound™ Silicone 15x15	2024-04-16 Self-Adherent Soft Silicone Foam Dressing with Border
00825439011454 - CovaWound™ Silicone 15x20	2024-04-16 Self-Adherent Soft Silicone Foam Dressing with Border
00825439011478 - CovaWound™ Silicone 7.5x7.5	2024-04-16 Self-Adherent Soft Silicone Foam Dressing
00825439011515 - CovaWound™ Silicone 12x12	2024-04-16 Self-Adherent Soft Silicone Foam Dressing
00825439011553 - CovaWound™ Silicone 15x20	2024-04-16 Self-Adherent Soft Silicone Foam Dressing
00825439012055 - CovaWound™ Silicone 18x18	2024-04-16 Self-Adherent Soft Silicone Foam Dressing with Border

Trademark Results [CovaView]

Mark Image Registration \| Serial	Company Trademark Application Date
COVAVIEW 87332134 not registered Live/Pending	Covalon Technologies Ltd. 2017-02-10