CovaClear™ IV 7.5x9 9600709

GUDID 00825439016411

Clear Silicone Adhesive Securement 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: 00825439016411
• NIH Device Record Key: aa79dba7-b329-4533-97f0-332961208837
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CovaClear™ IV 7.5x9
• Version Model Number: 9600709
• Catalog Number: 9600709
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 7.5 Centimeter
• Width: 9 Centimeter
• Length: 7.5 Centimeter
• Width: 9 Centimeter
• Length: 7.5 Centimeter
• Width: 9 Centimeter
• Length: 7.5 Centimeter
• Width: 9 Centimeter
• Length: 7.5 Centimeter
• Width: 9 Centimeter
• Length: 7.5 Centimeter
• Width: 9 Centimeter
• Length: 7.5 Centimeter
• Width: 9 Centimeter
• Length: 7.5 Centimeter
• Width: 9 Centimeter
• Length: 7.5 Centimeter
• Width: 9 Centimeter
• Length: 7.5 Centimeter
• Width: 9 Centimeter
• Length: 7.5 Centimeter
• Width: 9 Centimeter
• Length: 7.5 Centimeter
• Width: 9 Centimeter
• Length: 7.5 Centimeter
• Width: 9 Centimeter
• Length: 7.5 Centimeter
• Width: 9 Centimeter
• Length: 7.5 Centimeter
• Width: 9 Centimeter
• Length: 7.5 Centimeter
• Width: 9 Centimeter
• Length: 7.5 Centimeter
• Width: 9 Centimeter
• Length: 7.5 Centimeter
• Width: 9 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	00825439016404 [Primary]
GS1	00825439016411 [Package]; Contains: 00825439016404; Package: Carton [25 Units]; In Commercial Distribution
GS1	10825439016418 [Package]; Package: Shipper [4 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

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• 00825439011454 - CovaWound™ Silicone 15x20: 2024-04-16 Self-Adherent Soft Silicone Foam Dressing with Border
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• 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