iSED Elite 112-00222

GUDID 00850028040041

Automated Erythrocyte Sedimentation Rate Analyzer

ALCOR SCIENTIFIC INC.

Erthrocyte sedimentation rate (ESR) analyser IVD

• Primary Device ID: 00850028040041
• NIH Device Record Key: c6710d03-89fb-460d-a0c2-f5cbe52c4a2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iSED Elite
• Version Model Number: 112-00222
• Catalog Number: 112-00222
• 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	00850028040041 [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: 2023-11-13
• Device Publish Date: 2023-11-03

Devices Manufactured by ALCOR SCIENTIFIC INC.

• 00850028040041 - iSED Elite: 2023-11-13Automated Erythrocyte Sedimentation Rate Analyzer
• 00850028040041 - iSED Elite: 2023-11-13 Automated 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