Skin Temperature Probe,Disposable
N/A - M1024222
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
- 95.00
- 50.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: FLL
Device Name: Continuous Measurement Thermometer
Device Class: 2
Physical State: The device may be a patch that is applied on or a probe that is used with a patient. Patches may include adhesive backing to allow the device to adhere to the target location. Probes are used invasively or non-invasively and may be connected wired or wirelessly to a compatible monitor or other device.
Definition: A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf.
Submission Type ID: 1
Review Panel: HO
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: The device is a contact or non-contact thermometer indicated to measure a person’s temperature. Temperature may be measured continuously, at pre-specified intervals, or remotely at the request of the user. The device output is displayed either on the device or may be transferred to a compatible monitor or device via a wired or wireless connection.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: The device may be used externally on a person’s skin, used invasively including inside the esophagus or rectum, or ingested.
Regulation Number: 880.2910
Third Party Flag: Y
Medical Specialty: HO
Device Identifiers
Device Id: 70885403251629
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10885403251627
Package Quantity: 25
Package Discontinue Date: 3/31/2022 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Pack
Device Id: 10885403251627
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