SampLok® Sampling Kit 16mL A100756

GUDID 19555240405613

SSK 16mL is a device used to transfer sample from bllod bags or other containers with sterile docking compatible tubing to vacuum containers for in-vitro tests. Single use only. The device is for use by trained laboratory staff, in a laboratory

ITL ASIA PACIFIC SDN. BHD.

Blood/blood culture specimen transfer spike IVD, manual

• Primary Device ID: 19555240405613
• NIH Device Record Key: 568ef998-5ddf-4777-902d-7b43643886e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SampLok® Sampling Kit 16mL
• Version Model Number: A100756
• Catalog Number: A100756
• Company DUNS: 597723837
• Company Name: ITL ASIA PACIFIC SDN. BHD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +18884112851
• Email: sales@itlbiomedical.com
• Phone: +18884112851
• Email: sales@itlbiomedical.com
• Phone: +18884112851
• Email: sales@itlbiomedical.com
• Phone: +18884112851
• Email: sales@itlbiomedical.com
• Phone: +18884112851
• Email: sales@itlbiomedical.com
• Phone: +18884112851
• Email: sales@itlbiomedical.com
• Phone: +18884112851
• Email: sales@itlbiomedical.com
• Phone: +18884112851
• Email: sales@itlbiomedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Direct Sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	09555240405616 [Primary]
GS1	19555240405613 [Package]; Contains: 09555240405616; Package: Carton [110 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• BK030087

FDA Product Code

• KSS: Supplies, Blood-Bank

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: 2025-06-12
• Device Publish Date: 2025-06-04

On-Brand Devices [SampLok® Sampling Kit 16mL]

• 19555240400533: SampLok® Sampling Kit (SSK): SSK-Mk2-16mL is used to transfer samples from blood bags or other
• 19555240405613: SSK 16mL is a device used to transfer sample from bllod bags or other containers with sterile do