SampLok® With Hinged Lid A100422

GUDID 19555240400069

SampLok® Hinged Lid 11-18 (Wider Bore), Clear, Bulk, Non-Sterile; Intended as a needle holder for a Luer adapter needle to vacuum blood collection tube.

ITL ASIA PACIFIC SDN. BHD.

Blood collection tube holder, single-use

• Primary Device ID: 19555240400069
• NIH Device Record Key: 2d950c2c-ad3d-42de-ae96-cfbc3f83a5e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SampLok® With Hinged Lid
• Version Model Number: A100422
• Catalog Number: A100422
• Company DUNS: 597723837
• Company Name: ITL ASIA PACIFIC SDN. BHD.
• Device Count: 700
• 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 Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	09555240400062 [Unit of Use]
GS1	19555240400069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000777

FDA Product Code

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

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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