Level 1 - MTS-TC15
Device Description
A temperature sensing device intended to be placed into a body orifice or on the body surface, and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DTW
Device Name: Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.4340
Third Party Flag: N
Medical Specialty: CV
Device IdentifiersDevice Id: 20695085000539
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10695085000532
Package Quantity: 200
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX
Device Id: 10695085000532
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 30695085000536
Package Quantity: 20
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX
Device Id: 30695085000536
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
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