TransFix/EDTA Vacuum Blood Collection Tubes

GUDID 05060531711627

TransFix/EDTA Vacuum Blood Collection Tubes (TVTs) are intended for collection and storage of human whole blood specimens for immunophenotyping of whi

CALTAG MEDSYSTEMS LIMITED

Evacuated blood collection tube IVD, K3EDTA

• Primary Device ID: 05060531711627
• NIH Device Record Key: 814fb25f-2e12-4cf5-be67-97f5861e0424
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TransFix/EDTA Vacuum Blood Collection Tubes
• Version Model Number: TVT-03-50-US
• Company DUNS: 221434843
• Company Name: CALTAG MEDSYSTEMS LIMITED
• 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: 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: +441280827460
• Email: Cytomark@caltagmedsystems.co.u

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060531711627 [Primary]
GS1	15060531711624 [Package]; Package: Pouch [50 Units]
GS1	25060531711621 [Package]; Contains: 15060531711624; Package: Cardboard Box [10 Units]
GS1	35060531711628 [Package]; Package: Pouch [2 Units]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162723

FDA Product Code

• GIM: Tubes, Vacuum Sample, With Anticoagulant

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-02

Devices Manufactured by CALTAG MEDSYSTEMS LIMITED

• 05060531710019 - TransFix: 2023-10-02
• 05060531710026 - TransFix: 2023-10-02
• 15060531710030 - TransFix: 2023-10-02
• 15060531711600 - TransFix/EDTA Vacuum Blood Collection Tube: 2023-06-28 TransFix/EDTA Vacuum Blood Collection Tube to directly draw and stabilize whole blood for flow cytometric analysis.
• 05060531711627 - TransFix/EDTA Vacuum Blood Collection Tubes: 2018-07-06TransFix/EDTA Vacuum Blood Collection Tubes (TVTs) are intended for collection and storage of human whole blood specimens for immunophenotyping of whi
• 05060531711627 - TransFix/EDTA Vacuum Blood Collection Tubes: 2018-07-06 TransFix/EDTA Vacuum Blood Collection Tubes (TVTs) are intended for collection and storage of human whole blood specimens for im