Sercon

GUDID 05061024690009

ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS

SERCON LIMITED

Mass spectrometry analyser IVD Mass spectrometry analyser IVD Mass spectrometry analyser IVD Mass spectrometry analyser IVD Mass spectrometry analyser IVD Mass spectrometry analyser IVD Mass spectrometry analyser IVD Mass spectrometry analyser IVD Mass spectrometry analyser IVD Mass spectrometry analyser IVD Mass spectrometry analyser IVD Mass spectrometry analyser IVD 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