Excyte®

GUDID 03661540700668

ELITechGroup B.V.

Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD Evacuated erythrocyte sedimentation rate (ESR) tube IVD

• Primary Device ID: 03661540700668
• NIH Device Record Key: 60c215b3-0a8d-45f3-9f45-7013c82904b0
• Commercial Distribution Discontinuation: 2021-12-23
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Excyte®
• Version Model Number: Plastic ESR 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	03661540700668 [Primary]
GS1	13661540700665 [Unit of Use]

FDA Product Code

• GHC: Tube, Sedimentation Rate

Sterilization

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

[03661540700668]

Radiation Sterilization

[03661540700668]

Radiation Sterilization

[03661540700668]

Radiation Sterilization

[03661540700668]

Radiation Sterilization

[03661540700668]

Radiation Sterilization

[03661540700668]

Radiation Sterilization

[03661540700668]

Radiation Sterilization

[03661540700668]

Radiation Sterilization

[03661540700668]

Radiation Sterilization

[03661540700668]

Radiation Sterilization

[03661540700668]

Radiation Sterilization

[03661540700668]

Radiation Sterilization

[03661540700668]

Radiation Sterilization

[03661540700668]

Radiation Sterilization

[03661540700668]

Radiation Sterilization

[03661540700668]

Radiation Sterilization

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