Flex small 4 MR coil set 1.5T

GUDID 04056869014623

Contains Medical Device Mat. 10185553 (GTIN:04056869014791)

Siemens Healthcare GmbH

Full-body MRI system, superconducting magnet

• Primary Device ID: 04056869014623
• NIH Device Record Key: 3a0c3c27-5a77-4417-a156-eb54fcfc9cc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flex small 4 MR coil set 1.5T
• Version Model Number: 10185503
• Company DUNS: 313217003
• Company Name: Siemens Healthcare GmbH
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)888-7436
• Email: XX@XX.XX
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)888-7436
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056869014623 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121434

FDA Product Code

• LNI: System, nuclear magnetic resonance spectroscopic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by Siemens Healthcare GmbH

• 04056869962214 - YSIO X.pree: 2025-08-19
• 04056869993973 - LUMINOS Q.namix R: 2025-08-07
• 04056869993980 - LUMINOS Q.namix T: 2025-08-07
• 04068151010404 - AI-Rad Companion Organs RT: 2025-06-13
• 04056869973371 - AI-Rad Companion Organs RT: 2025-05-08
• 04056869994536 - syngo.CT Dual Energy: 2025-04-21
• 04056869973180 - Somatom On.site: 2025-04-15
• 04068151014655 - NAEOTOM Alpha.Pro: 2025-04-09