FDA.reportPublic FDA data

American Red Cross

Primary DI
84617503102012
Brand
American Red Cross
Company
CREATIVE CONCEPTS MANUFACTURING LIMITED
Model
PC868
Catalog number
AR3102
Device description
Intended UseThis infrared thermometer is intended to measure the body temperature of infants and adults without contact. It can also be used to measure surface temperatures of objects such as baby bottles, bath water, pool water, vents and more. Perfect for home, office or clinical use.
Published
2021-11-19
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
84617503102128PackageGS112In Commercial Distribution
84617503102012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
8461750310212884617503102128
8461750310201284617503102012

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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
84617503105013American Red CrossA201AR31052021-12-11
84617503106010American Red CrossKFT-05R31062021-12-11
84617503103019American Red CrossDET-103AR31032021-11-19
84617503109011American Red CrossFC-IR101AR31092021-09-24
84617503109127American Red CrossFC-IR101AR31092021-09-24
84617503100018American Red CrossJXB-178AR31002021-07-23
84617503104016American Red CrossPG-IRT1603AR31042021-07-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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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