Sercon

GUDID 05061024690009

ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS

SERCON LIMITED

Mass spectrometry analyser IVD

• Primary Device ID: 05061024690009
• NIH Device Record Key: 42b34bf3-60a0-41ea-951a-80f57f7b3aad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sercon
• Version Model Number: 20602
• Company DUNS: 222721313
• Company Name: SERCON LIMITED
• 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: 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

Customer Support Contacts

• Phone: +441270580008
• Email: mark.oconnor@sercongroup.com
• Phone: +441270580008
• Email: mark.oconnor@sercongroup.com
• Phone: +441270580008
• Email: mark.oconnor@sercongroup.com
• Phone: +441270580008
• Email: mark.oconnor@sercongroup.com
• Phone: +441270580008
• Email: mark.oconnor@sercongroup.com
• Phone: +441270580008
• Email: mark.oconnor@sercongroup.com
• Phone: +441270580008
• Email: mark.oconnor@sercongroup.com
• Phone: +441270580008
• Email: mark.oconnor@sercongroup.com
• Phone: +441270580008
• Email: mark.oconnor@sercongroup.com
• Phone: +441270580008
• Email: mark.oconnor@sercongroup.com
• Phone: +441270580008
• Email: mark.oconnor@sercongroup.com
• Phone: +441270580008
• Email: mark.oconnor@sercongroup.com
• Phone: +441270580008
• Email: mark.oconnor@sercongroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05061024690009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992163

FDA Product Code

• DOP: Mass Spectrometer, Clinical Use

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: 2023-09-07
• Device Publish Date: 2023-08-30