THERMOMETER, DIG ORAL LF
McKesson - 01-413BGM
Device Description
A hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. 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: 10612479128085
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
Device Id: 20612479134892
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10612479128085
Package Quantity: 12
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Box
Device Id: 40612479128277
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 20612479134892
Package Quantity: 12
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case
