SampLok® Adapter Cap 2 A100715

GUDID 19555240401226

The SampLok® Adapter Cap has a Luer thread which facilitates attachment with commonly available multi-sample Luer adaptor; It is intended to facilitate collection of blood sample into either a culture bottle or standard vacuum blood tubes. It is a single use device.

ITL ASIA PACIFIC SDN. BHD.

Blood collection tube holder, single-use

• Primary Device ID: 19555240401226
• NIH Device Record Key: 53d892e1-a719-493e-beda-e3e7ee3daf42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SampLok® Adapter Cap 2
• Version Model Number: A100715
• Catalog Number: A100715
• Company DUNS: 597723837
• Company Name: ITL ASIA PACIFIC SDN. BHD.
• Device Count: 40
• 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: 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	09555240401212 [Unit of Use]
GS1	19555240401219 [Primary]
GS1	19555240401226 [Package]; Contains: 19555240401219; Package: Carton [12 Units]; In Commercial Distribution

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

On-Brand Devices [SampLok® Adapter Cap 2]

• 19555240401226: The SampLok® Adapter Cap has a Luer thread which facilitates attachment with commonly available
• 19555240401301: The SampLok® Adapter Cap has a Luer thread which facilitates attachment with commonly available