SpotOn™ 37000

GUDID 00608223370001

3M™ SpotOn™ Temperature Monitoring System 37000

3M COMPANY

Continuous electronic patient thermometer, line-powered

• Primary Device ID: 00608223370001
• NIH Device Record Key: 3d14e5fc-8a3d-4ccd-b9c4-c4228040a327
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpotOn™
• Version Model Number: 37000
• Catalog Number: 37000
• Company DUNS: 830016148
• Company Name: 3M 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: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com
• Phone: +1(800)228-3957
• Email: 3Mhealthcarecompliance@mmm.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00608223370001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120412

FDA Product Code

• FLL: Thermometer, electronic, clinical

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

On-Brand Devices [SpotOn™]

• 00608223370001: 3M™ SpotOn™ Temperature Monitoring System 37000
• 00849593002332: 3M™ SpotOn™ Temperature Cable, Draeger to Mini Phone Jack 90132
• 00849593002325: 3M™ SpotOn™ Temperature Cable, Phillips/Mindray to Mini Phone Jack 90130
• 00849593002318: 3M™ SpotOn™ Temperature Cable, Spacelabs to Mini Phone Jack 90133
• 00849593002301: 3M™ SpotOn™ Temperature Cable, GE to Mini Phone Jack 90131
• 50608223360007: 3M™ SpotOn™ Temperature Monitoring Sensor, Non Sterile, 25 Per Case 36000