DEVICE: RightCare (00850018898096)
Device Identifier (DI) Information
RightCare
RCIRDT / JXB-178
In Commercial Distribution
Outsource Pharmacy Solutions Inc.
RCIRDT / JXB-178
In Commercial Distribution
Outsource Pharmacy Solutions Inc.
RightCare No-Touch Infrared Forehead Thermometer with Instant Results for School, Home, and Businesses, 1 Count
NON-CONTACT SENSOR allows for safe, non-invasive body temperature readings at least 2 inches from forehead. Easy to use with adults and children. New 2020 generation sensor is designed with an advanced algorithm that provides faster, more accurate results
INSTANT ACCURATE READINGS in Fahrenheit or Celsius display on the large, easy-to-read back lit LCD screen within .5 seconds. The infrared sensor and fast microprocessor can detect thermal heat on bodies and surfaces. Only use in an ambient temperature range between 50 degrees F and 104 degrees F
MULTIFUNCTIONAL DESIGN for use by healthcare professionals or consumers. It's perfect for any doctor's office, clinic, hospital, school, workplace, and household. It's equipped with three modes: Body, Room, and Surface Temperature
COLORED DISPLAY AND AUDIBLE TONE makes it easy to identify safe temperatures. Green indicates normal, orange indicates a slight fever, and red with an audible tone indicates a high fever. The audible tone setting can be turned off if desired
32 SETS OF DATA STORAGE allows you to save and keep track of your temperatures with the click of a button. Includes enough storage room to easily record and track changes in family members temperature as well. Includes 1 Thermometer and 2 AA Batteries, Limited 18 month manufacturer warranty
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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17888 | Infrared patient thermometer, skin |
A hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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FLL | Thermometer, Electronic, Clinical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
781ce2d3-3121-40f5-b3c3-1b5d59ec7cbe
November 26, 2024
1
November 18, 2024
November 26, 2024
1
November 18, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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00850018898188 | 50 | 00850018898096 | In Commercial Distribution | CASE |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined