VACU-TEC DOUBLE LABEL 10200/W

GUDID 08033891320546

DIESSE DIAGNOSTICA SENESE SPA

Evacuated erythrocyte sedimentation rate (ESR) tube IVD

• Primary Device ID: 08033891320546
• NIH Device Record Key: 220b4fc9-bc36-4352-b796-fd56c1028e0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VACU-TEC DOUBLE LABEL
• Version Model Number: 10200/W
• Catalog Number: 10200/W
• Company DUNS: 435036669
• Company Name: DIESSE DIAGNOSTICA SENESE SPA
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033891320546 [Primary]

FDA Product Code

• GHC: Tube, Sedimentation Rate

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-05
• Device Publish Date: 2022-11-25

Devices Manufactured by DIESSE DIAGNOSTICA SENESE SPA

• 08033891322571 - CHORUS CLEANING SOLUTION 2000: 2026-03-31
• 08033891322588 - ENZY-WELL/CHORUS WASHING BUFFER: 2026-03-31
• 08033891322595 - CHORUS NEGATIVE CONTROL/SAMPLE DILUENT: 2026-03-31
• 08033891322816 - CHORUS EVO DECONTAMINATION BUFFER: 2026-03-31
• 08033891322823 - CHORUS EVO SANITIZING SOLUTION: 2026-03-31
• 08033891323103 - CHORUS WASHING BUFFER AUTOIMMUNITY: 2026-03-31
• 08033891328849 - CHORUS SANITIZING SOLUTION: 2026-03-31
• 08033891322748 - CHORUS CLIA CLOSTRIDIUM DIFFICILE GDH: 2025-08-27