SECURIS SK00001

GUDID 10801741085731

DOT SECURIS STABN DEVICE SEPP W/ALCOHOL

Bard Access Systems, Inc.

Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder Wearable percutaneous catheter/tube holder

• Primary Device ID: 10801741085731
• NIH Device Record Key: 9de65dc2-8fb1-4f87-b035-aed62f74358f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SECURIS
• Version Model Number: SK00001
• Catalog Number: SK00001
• Company DUNS: 044611812
• Company Name: Bard Access Systems, Inc.
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741085734 [Primary]
GS1	10801741085731 [Package]; Contains: 00801741085734; Package: Case [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: 2023-11-17
• Device Publish Date: 2023-11-09

On-Brand Devices [SECURIS]

• 10801741075466: SECURIS STABILIZATION DEVICE w/DFU, 1000 units, SECNS01
• 20801741075456: SECURIS STABILIZATION DEVICE
• 10801741085731: DOT SECURIS STABN DEVICE SEPP W/ALCOHOL