Excyte®

GUDID 03661540700613

ELITechGroup B.V.

Non-evacuated erythrocyte sedimentation rate (ESR) tube IVD

• Primary Device ID: 03661540700613
• NIH Device Record Key: 76f8c9e8-d923-4fca-8b5f-06f0f6fdf1c3
• Commercial Distribution Discontinuation: 2021-12-23
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Excyte®
• Version Model Number: ESR Non-Vacuum Tube
• Company DUNS: 415733737
• Company Name: ELITechGroup B.V.
• Device Count: 50
• 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	03661540700613 [Primary]
GS1	13661540700610 [Unit of Use]

FDA Product Code

• GHC: Tube, Sedimentation Rate

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-12-28
• Device Publish Date: 2016-11-24

On-Brand Devices [Excyte® ]

• 03661540700675: Plastic ESR Vacuum Tube High Altitude
• 03661540700668: Plastic ESR Vacuum Tube
• 03661540700613: ESR Non-Vacuum Tube
• 03661540700606: ESR Vacuum Tube
• 03661540700446: DUO-MIX
• 03661540700125: 20
• 03661540700118: 20
• 03661540700071: Mini
• 03661540700064: Mini