ACL TOP 700 CTS 00000280050R

GUDID 08426950928010

ACL TOP 700 CTS (Refurbished)

INSTRUMENTATION LABORATORY COMPANY

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• Primary Device ID: 08426950928010
• NIH Device Record Key: 16e77e50-787d-4c8c-a0d0-e9501f1c8dce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACL TOP 700 CTS
• Version Model Number: 00000280050R
• Catalog Number: 00000280050R
• 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: false
• 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: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com
• Phone: 18006780710
• Email: techsupport.na@werfen.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426950928010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160276

FDA Product Code

• GKP: INSTRUMENT, COAGULATION, AUTOMATED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-07-08
• Device Publish Date: 2016-09-23

On-Brand Devices [ACL TOP 700 CTS]

• 08426950928010: ACL TOP 700 CTS (Refurbished)
• 08426950497981: ACL TOP 700 CTS