FDA.reportPublic FDA data

FeverScan

Primary DI
10815236021098
Brand
FeverScan
Company
LCR HALLCREST, LLC.
Model
1023B NDP
Catalog number
FT45
Published
2022-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KPDStrip, Temperature, Forehead, Liquid Crystal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPDStrip, Temperature, Forehead, Liquid CrystalGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815236021098PackageGS11In Commercial Distribution
20815236021095PackageGS11In Commercial Distribution
30815236021092PackageGS112In Commercial Distribution
00815236021091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081523602109810815236021098
2081523602109520815236021095
3081523602109230815236021092
00815236021091008152360210918152360210910815236021091

GMDN Terms#

Term, Definition table
TermDefinition
Liquid-crystal patient thermometer, reusableA device designed to measure a patient's skin, oral, rectal, or axillary (armpit) body temperature. It uses liquid-crystal sensors (usually formed from esters of cholesterol) that are sealed in a plastic band and appear to change colour at indicated temperatures. The device may be used in the home. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
059247507
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10815236020671FeverScanBB150BB1502016-09-24
10815236020695FeverScanBB150BB1502016-09-24
00815236020926HemoTemp II Activator90002022-06-16
10815236021050HemoTemp20002022-06-20
10815236021074TempTrend II11002022-06-20
10815236021104StaFreez50002022-06-20
10815236021135LabTemp 4061002022-06-20
20815236021057HemoTemp20002022-06-20
20815236021071TempTrend II11002022-06-20
20815236021101StaFreez50002022-06-20
20815236021132LabTemp 4061002022-06-20
10815236021128LabTemp 2060002022-06-16
10815236020923HemoTemp II Activator90002022-06-16
20815236021125LabTemp 2060002022-06-16
10815236020176Crystaline® Moving Line5101C-MLC5101C-MLC2022-03-01
10815236020183Crystaline® Moving Line5101H-MLC5101H-MLC2022-03-01
10815236020190Crystaline® Moving Line5101SD-MLC5101SD-MLC2022-03-01
10815236020206Crystaline® Moving Line5101SB-MLC5101SB-MLC2022-03-01
20815236020173Crystaline® Moving Line5101C-MLC5101C-MLC2022-03-01
20815236020180Crystaline® Moving Line5101H-MLC5101H-MLC2022-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850053907173Xpect / Temp-N-TossCintas Corporation No. 2KPD2025-03-20
10850053907170Xpect / Temp-N-TossCintas Corporation No. 2KPD2025-03-20
00850018561204LC Accu-Bar Temperature Trend IndicatorINTERNATIONAL BIOMEDICAL, LTD.KPD2023-06-20
00057565168102FeverScan Fever Indicators by Physio LogicA.M.G. Médicale IncKPD2023-06-13
00057565976042FeverScan Fever Indicators by Physio LogicA.M.G. Médicale IncKPD2023-06-13
10815236021074TempTrend IILCR HALLCREST, LLC.KPD2022-06-20
20815236021071TempTrend IILCR HALLCREST, LLC.KPD2022-06-20
10815236020176Crystaline® Moving LineLCR HALLCREST, LLC.KPD2022-03-01
10815236020183Crystaline® Moving LineLCR HALLCREST, LLC.KPD2022-03-01
10815236020190Crystaline® Moving LineLCR HALLCREST, LLC.KPD2022-03-01
10815236020206Crystaline® Moving LineLCR HALLCREST, LLC.KPD2022-03-01
20815236020173Crystaline® Moving LineLCR HALLCREST, LLC.KPD2022-03-01
20815236020180Crystaline® Moving LineLCR HALLCREST, LLC.KPD2022-03-01
20815236020197Crystaline® Moving LineLCR HALLCREST, LLC.KPD2022-03-01
00815236020209Crystaline® Moving LineLCR HALLCREST, LLC.KPD2022-03-01
00050428313176CVS FOREHEAD THERMOMETERWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKPD2022-02-25
00815236021091FeverScanLCR HALLCREST, LLC.KPD2022-01-04
00815236020933Peppa PigLCR HALLCREST, LLC.KPD2021-12-09
10190752144484Vital Signs™AIRLIFEKPD2021-05-07
50190752144482Vital Signs™VYAIRE MEDICAL, INC.KPD2021-05-07
10888277681958MedlineMEDLINE INDUSTRIES, INC.KPD2020-12-10
20888277681955MedlineMEDLINE INDUSTRIES, INC.KPD2020-12-10
30815236020101Crystaline IILCR HALLCREST, LLC.KPD2020-10-26
30815236020323TempAlert IILCR HALLCREST, LLC.KPD2020-10-26
00815236021046FeverScan Mini DisposableLCR HALLCREST, LLC.KPD2020-10-26
10815236021043FeverScan Mini DisposableLCR HALLCREST, LLC.KPD2020-10-26
00815236020100Crystaline IILCR HALLCREST, LLC.KPD2020-10-26
00815236020322TempAlert IILCR HALLCREST, LLC.KPD2020-10-26
00029431000021ATI, Inc.AMERICAN THERMAL INSTRUMENTS, INC.KPD2020-09-30
00029431000038ATI, Inc.AMERICAN THERMAL INSTRUMENTS, INC.KPD2020-09-30