Truer Medical, Inc. GP 14400

GUDID 00859290006120

Truer Medical General Purpose Probes are designed for continuous temperature monitoring. Probes can be introduced through oral or rectal openings. Probes tips have special low-friction “frosted” finish to aid in the ease of placement and patient comfort.

TRUER MEDICAL, INC.

General-purpose patient temperature probe, single-use

• Primary Device ID: 00859290006120
• NIH Device Record Key: e3029b49-8061-42be-b1e5-20b6df590201
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Truer Medical, Inc.
• Version Model Number: GP 14400
• Catalog Number: GP 14400
• Company DUNS: 003530786
• Company Name: TRUER MEDICAL, INC.
• 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: true
• Expiration Date: true
• 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: (714) 628-9875
• Email: cpescador@truermedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859290006120 [Primary]
GS1	10859290006127 [Package]; Package: Carton [25 Units]; In Commercial Distribution
GS1	20859290006124 [Package]; Contains: 10859290006127; Package: Carton [2 Units]; In Commercial Distribution
GS1	30859290006121 [Package]; Contains: 20859290006124; Package: Carton [5 Units]; In Commercial Distribution
GS1	40859290006128 [Package]; Contains: 20859290006124; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101244

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: 2016-06-06

On-Brand Devices [Truer Medical, Inc.]

• 30859290006145: The Truer Medical Skin Temperature Sensor is designed for monitoring a patient’s skin surface
• 40859290006135: The Truer Medical Skin Temperature Sensor is designed for monitoring a patient’s skin surface
• 00859290006120: Truer Medical General Purpose Probes are designed for continuous temperature monitoring. Probes
• 00859290006113: Truer Medical General Purpose Probes are designed for continuous temperature monitoring. Probes
• 00859290006106: The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgica
• 00859290006090: The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgica
• 00859290006083: The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgica
• 00859290006076: The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgica
• 00859290006069: The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgica
• 00859290006052: The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgica
• 00859290006045: The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgica
• 00859290006038: The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgica
• 00859290006021: The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgica
• 00859290006014: The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgica
• 00859290006007: The Truer Medical disposable Esophageal Stethoscope with Temperature Sensor is used in a surgica