TransFix/EDTA Vacuum Blood Collection Tube TVT-03-50

GUDID 15060531711600

TransFix/EDTA Vacuum Blood Collection Tube to directly draw and stabilize whole blood for flow cytometric analysis.

CALTAG MEDSYSTEMS LIMITED

Evacuated blood collection tube IVD, anticoagulant/cell preservative

• Primary Device ID: 15060531711600
• NIH Device Record Key: 1d21a5f5-5a41-4037-be30-22492f89cea5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TransFix/EDTA Vacuum Blood Collection Tube
• Version Model Number: KC1030
• Catalog Number: TVT-03-50
• Company DUNS: 221434843
• Company Name: CALTAG MEDSYSTEMS LIMITED
• Device Count: 1
• DM Exempt: true
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060531711603 [Primary]
GS1	05060531711627 [Previous]
GS1	15060531711600 [Package]; Contains: 05060531711603; Package: Foil Pouch [50 Units]; In Commercial Distribution
GS1	35060531711604 [Package]; Contains: 05060531711603; Package: Foil Pouch [1 Units]; In Commercial Distribution
GS1	45060531711601 [Package]; Contains: 05060531711603; Package: Foil Pouch [2 Units]; In Commercial Distribution

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-28
• Device Publish Date: 2023-06-20

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