SampLok® System with Hinged Lid A100645

GUDID 19555240400007

SampLok® System with Hinged Lid (Wider Bore), Clear Assembled with PP Luer, Individual Packaged Sterile; Intended to be used as a part of vacuum blood collection equipment for the collection of blood samples for various types of blood tests

ITL ASIA PACIFIC SDN. BHD.

Blood collection tube holder/needle

• Primary Device ID: 19555240400007
• NIH Device Record Key: b1c619af-4e42-46bc-98be-716284af33cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SampLok® System with Hinged Lid
• Version Model Number: A100645
• Catalog Number: A100645
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	19555240400007 [Package]; Contains: 19555240401158; Package: Carton [425 Units]; In Commercial Distribution
GS1	19555240401158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021941

FDA Product Code

• JKA: Tubes, Vials, Systems, Serum Separators, Blood Collection

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: 2019-04-08
• Device Publish Date: 2019-03-29

On-Brand Devices [SampLok® System with Hinged Lid]

• 19555240400007: SampLok® System with Hinged Lid (Wider Bore), Clear Assembled with PP Luer, Individual Packaged
• 19555240400076: SampLok® Hinged Lid (Wide Bore), Clear, Assembled with PP Luer with Isoprene Sleeve, Bulk, Non-
• 19555240400045: SampLok® Hinged Lid (Wide Bore), Clear, Assembled with PC Luer with Isoprene Sleeve, Bulk, Non-