CAPIOX Luer Thermistor

CAPIOX Luer Thermistor
CAPIOX - CX*TL

An electronic device that is a module of a cardiopulmonary bypass system and that is used to measure and display the temperatures of the different temperature probes that are connected into the total system in order to monitor the fluid and blood temperatures at various points. It may also control the temperature levels, e.g., the temperature level of the fluid entering and leaving the heat exchanger.

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 54987350706336

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04987350706331

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 04987350706331

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