ADTEMP Digital Sheaths,100/pkg

ADTEMP Digital Sheaths,100/pkg
Adtemp™ - 416-100

A device intended to be used as a physical barrier between the patient and the probe of a thermometer that uses electronics to create the measurement, e.g., a tympanic (in-the-ear) or electronic (body) thermometer, to prevent cross-contamination between patients. This is a single-use device.

No Data Available

No Data Available

Device Sterile: False

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: 00634782502522

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00634782002534

Package Quantity: 50

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Master Case

Device Id: 00634782002534

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