Level 1 - C400-5
Device Description
A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
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: 30695085002967
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10695085002963
Package Quantity: 100
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: BOX
Device Id: 10695085002963
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