ACL TOP 570 00000280047

GUDID 00195226000559

ACL TOP 570

INSTRUMENTATION LABORATORY COMPANY

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• Primary Device ID: 00195226000559
• NIH Device Record Key: 9899fcc8-139b-4f31-a520-d79bac7ca7b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACL TOP 570
• Version Model Number: 00000280047
• Catalog Number: 00000280047
• Company DUNS: 557223252
• Company Name: INSTRUMENTATION LABORATORY COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 800-678-0710
• Email: techsupport.na@werfen.com
• Phone: 800-678-0710
• Email: techsupport.na@werfen.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195226000559 [Primary]

FDA Product Code

• GKP: Instrument, Coagulation, Automated

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: 2024-05-23
• Device Publish Date: 2024-05-15

Devices Manufactured by INSTRUMENTATION LABORATORY COMPANY

• 00195226000528 - ACL TOP 770: 2024-05-23 ACL TOP 770
• 00195226000535 - ACL TOP 770 LAS: 2024-05-23 ACL TOP 770 LAS
• 00195226000542 - ACL TOP 770s: 2024-05-23 ACL TOP 770s
• 00195226000559 - ACL TOP 570: 2024-05-23ACL TOP 570
• 00195226000559 - ACL TOP 570: 2024-05-23 ACL TOP 570
• 00195226000566 - ACL TOP 370: 2024-05-23 ACL TOP 370
• 00195226000641 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 300 Tests): 2023-10-11 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (300 T
• 00195226000627 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 600 Tests): 2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (600 T
• 00195226000634 - GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 450 Tests): 2023-10-10 GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (450 T