TEMPTRAC® 1952-1

GUDID 10650551046322

TEMPERATURE MONITORING SURFACE/SUBSURFACE ELECTRODE

PMT CORPORATION

General-purpose patient temperature probe, single-use General-purpose patient temperature probe, single-use

• Primary Device ID: 10650551046322
• NIH Device Record Key: dcca6e94-9b0b-4cd7-9e35-e9f3118b0a27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEMPTRAC®
• Version Model Number: 1952-1
• Catalog Number: 1952-1
• Company DUNS: 039576871
• Company Name: PMT CORPORATION
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-626-5463
• Email: info@pmtcorp.com
• Phone: 800-626-5463
• Email: info@pmtcorp.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00650551046325 [Primary]
GS1	10650551046322 [Package]; Contains: 00650551046325; Package: BOX [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K830530

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-12

On-Brand Devices [TEMPTRAC®]

• 10650551046339: TEMPERATURE MONITORING NEEDLE ELECTRODE
• 10650551046322: TEMPERATURE MONITORING SURFACE/SUBSURFACE ELECTRODE