SampLok® Adapter Cap Kit A100704

GUDID 19555240400199

SampLok® Adaptor Cap Kit (SampLok® Adaptor Cap, clear, assembled with PP Luer, bulk, non-sterile); It is intended to facilitate collection of blood samples into either a culture bottle or standard vacuum blood tubes.

ITL ASIA PACIFIC SDN. BHD.

Blood collection tube holder, single-use

• Primary Device ID: 19555240400199
• NIH Device Record Key: b8a03b62-6a0d-4a22-a367-e05e9bc78749
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SampLok® Adapter Cap Kit
• Version Model Number: A100704
• Catalog Number: A100704
• Company DUNS: 597723837
• Company Name: ITL ASIA PACIFIC SDN. BHD.
• Device Count: 300
• 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: false
• Expiration Date: false
• 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	09555240400192 [Unit of Use]
GS1	19555240400199 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021941

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-23
• Device Publish Date: 2019-03-29

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