FDA.reportPublic FDA data

W.W. Grainger, Inc.,

Primary DI
00194484319427
Brand
W.W. Grainger, Inc.,
Company
GRAINGER INTERNATIONAL, INC.
Model
THD2FE
Catalog number
56JN58
Device description
Non-Contact Forehead Thermometer
Published
2020-05-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121428000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121428000NON-CONTACT CLINICAL THERMOMETERRadiant Innovation, Inc.2012-07-17FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00194484319427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00194484319427001944843194271944843194270194484319427

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, skinA hand-held, battery-powered, electronic 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

Regulatory Flags#

DUNS number
053618240
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10194484322035CONDOR1AGG8B2025-12-22
10194484322042CONDOR1AGG9B2025-12-22
10194484322059CONDOR1AGH1B2025-12-22
10194484322073CONDOR1AGH3B2025-12-22
10194484322080CONDOR1AGH4B2025-12-22
10194484322097CONDOR1AGH5B2025-12-22
10194484322103CONDOR1AGH6B2025-12-22
10194484322110CONDOR3RXT4B2025-12-22
10194484322127CONDOR3RXT5B2025-12-22
10194484322134CONDOR3RXT6B2025-12-22
10194484322141CONDOR3RXT7B2025-12-22
10194484322158CONDOR3RXT8B2025-12-22
10194484322165CONDOR3RXT9B2025-12-22
10194484322189CONDOR3RXU2B2025-12-22
10194484322196CONDOR3RXU3B2025-12-22
10194484322202CONDOR3RXU4B2025-12-22
10194484322219CONDOR3RXU5B2025-12-22
10194484322226CONDOR3RXU6B2025-12-22
10194484322233CONDOR3RXU7B2025-12-22
10194484322240CONDOR3RYC4B2025-12-22

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