IV Clear 10x12cm cover dressing

GUDID 00825439010389

Antimicrobial clear silicone adhesive dressing

Covalon Technologies Ltd

Antimicrobial synthetic polymer semi-permeable film dressing, adhesive

• Primary Device ID: 00825439010389
• NIH Device Record Key: ecadf406-b26a-46b4-bd9a-c4a918dd273f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IV Clear 10x12cm cover dressing
• Version Model Number: TWBD1012
• Company DUNS: 206936101
• Company Name: Covalon Technologies Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• 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: 12 Centimeter
• Width: 10 Centimeter
• Length: 12 Centimeter
• Width: 10 Centimeter
• Length: 12 Centimeter
• Width: 10 Centimeter
• Length: 12 Centimeter
• Width: 10 Centimeter
• Length: 12 Centimeter
• Width: 10 Centimeter
• Length: 12 Centimeter
• Width: 10 Centimeter
• Length: 12 Centimeter
• Width: 10 Centimeter
• Length: 12 Centimeter
• Width: 10 Centimeter

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Humidity: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00825439010389 [Package]; Contains: 00825439010457; Package: Carton [25 Units]; In Commercial Distribution
GS1	00825439010457 [Primary]
GS1	10825439010386 [Package]; Package: Shipper [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112549

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2022-12-08
• Device Publish Date: 2022-11-30

Devices Manufactured by Covalon Technologies Ltd

• 00825439017487 - CovaClear™ IV Cover 4x4: 2024-09-09 Clear Silicone Adhesive Securement Dressing
• 00825439017500 - CovaClear™ IV Cover 6x7: 2024-09-09 Clear Silicone Adhesive Securement Dressing
• 00825439017524 - CovaClear™ IV Cover 10x12: 2024-09-09 Clear Silicone Adhesive Securement Dressing
• 00825439017548 - CovaClear™ IV 10x12: 2024-09-09 Clear Silicone Adhesive Securement Dressing
• 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