FDA.reportPublic FDA data

Temp-n-Toss

Primary DI
10029431000004
Brand
Temp-n-Toss
Company
AMERICAN THERMAL INSTRUMENTS, INC.
Model
C-8735
Device description
Disposable Forehead Thermometer
Published
2020-08-11
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
true

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
00029431005040PackageGS15000In Commercial Distribution
10029431000004PackageGS167200In Commercial Distribution
20029431000001PackageGS15000In Commercial Distribution
00029431000007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00029431005040000294310050400294310050400029431005040
1002943100000410029431000004
2002943100000120029431000001
00029431000007000294310000070294310000070029431000007

GMDN Terms#

Term, Definition table
TermDefinition
Colour-indication patient thermometerA device designed to measure a patient's skin, oral, rectal, or axillary (armpit) body temperature. The device records body temperature using heat sensitive chemical cells (dots) which are sealed at the end of a plastic or metal strip. Body heat causes a colour change in the heat sensitive chemicals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
004200824
Device count
1
DM exempt
false
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00029431000007Temp-n-TossC-87352020-08-11
00029431000021ATI, Inc.C-87502020-09-30
00029431000038ATI, Inc.C-87802020-09-30
00029431000045ATI, Inc.C-87862020-09-30
00029431004982ATI, Inc.C-87022020-09-30
00029431000847ATI, Inc.C-87202020-08-11
00029431000014ATI, Inc.C-87862020-09-30
00029431001066ATI, Inc.C-87502020-09-30
00029431006559ATI, Inc.C-87802020-09-30

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
10815236021098FeverScanLCR 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