SCU Wide Cap Sampler A100723

GUDID 09555240404985

SCU Wide Cap Sampler is a needleless device used to transfer samples from blood culture bottles for blood culture testing. For 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

• Primary Device ID: 09555240404985
• NIH Device Record Key: 140fffa5-a128-4f72-8260-091c25843155
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCU Wide Cap Sampler
• Version Model Number: A100723
• Catalog Number: A100723
• Company DUNS: 597723837
• Company Name: ITL ASIA PACIFIC SDN. BHD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09555240404985 [Primary]
GS1	19555240404982 [Package]; Package: Inner Box [48 Units]; In Commercial Distribution
GS1	29555240404989 [Package]; Contains: 19555240404982; Package: Carton [6 Units]; In Commercial Distribution

FDA Product Code

• LIB: Device, General Purpose, Microbiology, Diagnostic

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: 2024-12-19
• Device Publish Date: 2024-12-11

Devices Manufactured by ITL ASIA PACIFIC SDN. BHD.

• 09555240404985 - SCU Wide Cap Sampler: 2024-12-19SCU Wide Cap Sampler is a needleless device used to transfer samples from blood culture bottles for blood culture testing. For single use only. The device is for use by trained laboratory staff, in a laboratory.
• 09555240404985 - SCU Wide Cap Sampler: 2024-12-19 SCU Wide Cap Sampler is a needleless device used to transfer samples from blood culture bottles for blood culture testing. For s
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• 19555240400083 - TiMO™ Tube Management Holder: 2021-06-28 TiMO™ is intended as a sample test tube holder to assist with the management of the sample tubes during blood collection.