Adtemp™ Hypothermia, Digital Thermometer, 10/18 sec, Bulk

Adtemp™ Hypothermia, Digital Thermometer, 10/18 sec, Bulk
Adtemp™ - 419

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.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: SDV

Device Name: Clinical Electronic Thermometer

Device Class: 2

Physical State: The device is portable and may be connected wired or wirelessly to another device. It uses a sensor to intermittently measure body temperature either by direct contact or via a non-contact infrared sensor.

Definition: A clinical electronic thermometer is a device used to intermittently measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. This product code is class II exempt, and was exempted, subject to the limitations of exemption, under the procedures established by section 510(m) of the FD&C Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 880.9 and the specific limitations of exemption as stated in the final order, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf

Submission Type ID: 4

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: A clinical electronic thermometer is a device used to intermittently measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The device does not have telethermographic or continuous temperature measurement functions.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Common measurement sites include the sublingual space in the mouth, rectum, ear canal, armpit, or the forehead

Regulation Number: 880.2910

Third Party Flag: N

Medical Specialty: HO

Device Id: 00634782553050

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00634782853051

Package Quantity: 20

Package Discontinue Date: 5/14/2019 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Master Case

Device Id: 00634782853051

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00634782053260

Package Quantity: 25

Package Discontinue Date: 5/14/2019 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Inner Pack

Device Id: 00634782053260

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: 00634782853044

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00634782053260

Package Quantity: 12

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Inner Pack

Device Id: 00634782500054

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00634782853044

Package Quantity: 12

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Master Case