iSED 112-00101

GUDID 00896406002508

Automated Erythrocyte Sedimentation Rate Analyzer

ALCOR SCIENTIFIC INC.

Erthrocyte sedimentation rate (ESR) analyser IVD, automated Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD Erthrocyte sedimentation rate (ESR) analyser IVD

• Primary Device ID: 00896406002508
• NIH Device Record Key: 2dcbd174-8ce9-4550-b4c3-18dacc831e85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iSED
• Version Model Number: 112-00101
• Catalog Number: 112-00101
• Company DUNS: 884153748
• Company Name: ALCOR SCIENTIFIC INC.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00896406002508 [Primary]

FDA Product Code

• GKB: Device, Automated 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: 2020-01-17
• Device Publish Date: 2020-01-09

Devices Manufactured by ALCOR SCIENTIFIC INC.

• 00850028040041 - iSED Elite: 2023-11-13 Automated Erythrocyte Sedimentation Rate Analyzer
• 00896406002508 - iSED: 2020-01-17Automated Erythrocyte Sedimentation Rate Analyzer
• 00896406002508 - iSED: 2020-01-17 Automated Erythrocyte Sedimentation Rate Analyzer
• 00896406002874 - miniiSED: 2020-01-17 Automated Erythrocyte Sedimentation Rate Analyzer
• 00896406002614 - Alcor SENTINELplus: 2019-10-23 Enteral Feeding Pump Bag Set, ENFit 1200ml, adapter, NS
• 00896406002621 - Alcor SENTINELplus: 2019-10-23 Enteral Feeding Pump Spike Set, ENFit, adapter, NS
• 00896406002638 - Alcor SENTINELplus: 2019-10-23 Enteral Feeding Gravity Set, ENFit, secure lock tip, adapter, NS
• 00896406002645 - Alcor SENTINELplus: 2019-10-23 Enteral Feeding Pump Bag Set, 1200ml, NS
• 00896406002652 - Alcor SENTINELplus: 2019-10-23 Enteral Feeding Pump Bag Set, 500ml, NS