FDA.reportPublic FDA data

American Red Cross

Primary DI
84617503100018
Brand
American Red Cross
Company
CREATIVE CONCEPTS MANUFACTURING LIMITED
Model
JXB-178
Catalog number
AR3100
Device description
Non-Contact Infrared Thermometer - Quick and Easy Body, Surface and Room Temperature ReadingsSafe, non-contact thermometer for quick 1 second temperature results in Fahrenheit or Celsius. Multiple operation modes perfect for reading body, room, or surface temperatures with the press of a button. Body mode backlit display illuminates green, yellow or red to clearly indicate normal and elevated temperatures
Published
2021-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
84617503100124PackageGS112In Commercial Distribution
84617503100018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
8461750310012484617503100124
8461750310001884617503100018

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, skinA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-201-656-2077contact@creativeconceptsusa.com

Regulatory Flags#

DUNS number
680004711
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
84617503105013American Red CrossA201AR31052021-12-11
84617503106010American Red CrossKFT-05R31062021-12-11
84617503102012American Red CrossPC868AR31022021-11-19
84617503103019American Red CrossDET-103AR31032021-11-19
84617503109011American Red CrossFC-IR101AR31092021-09-24
84617503109127American Red CrossFC-IR101AR31092021-09-24
84617503104016American Red CrossPG-IRT1603AR31042021-07-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06972040114341N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06972040115522N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06931973457093CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06931973457109CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06970758502641CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06970758508865CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
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