FDA.reportPublic FDA data

NEODOT

Primary DI
00850024759114
Brand
NEODOT
Company
Slv Pharmaceuticals LLC
Model
CK-T1502
Device description
Non-Contact Infrared Thermometer
Published
2020-11-16
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
K193253000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193253000Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503Shenzhen Changkun Technology Co., Ltd.2020-06-17FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850024759114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850024759114008500247591148500247591140850024759114

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

Regulatory Flags#

DUNS number
081225162
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00373317624512AUMSAFETY PEN NEEDLES 32G -4MM2022-03-08
00373317628442AUMMINI PEN NEEDLES 31G - 4MM2022-03-08
00373317628459AUMMINI PEN NEEDLES 31G - 5MM2022-03-08
00373317628466AUMMINI PEN NEEDLES 31G - 6MM2022-03-08
00373317628480AUMMINI PEN NEEDLES 31G - 8MM2022-03-08
00373317628541AUMMINI PEN NEEDLES 32G - 4MM2022-03-08
00373317628558AUMMINI PEN NEEDLES 32G - 5MM2022-03-08
00373317628565AUMMINI PEN NEEDLES 32G - 6MM2022-03-08
00373317628589AUMMINI PEN NEEDLES 32G - 8MM2022-03-08
00373317628640AUMMINI PEN NEEDLES 33G - 4MM2022-03-08
00373317628657AUMMINI PEN NEEDLES 33G - 5MM2022-03-08
00373317628664AUMMINI PEN NEEDLES 33G - 6MM2022-03-08
00373317464712BREATH COMFORTHUMIDIFIER2022-03-08
00373317495211BREATHE COMFORT OPTICHAMBERS2022-03-08
00373317495228BREATHE COMFORT OPTICHAMBERS2022-03-08
00373317568212AUMMOISTURIZING GEL SOCKS 2022-03-08
00373317000064AUMSAFETY PEN NEEDLES 32G -4MM2022-03-08
00373317000033AUMMINI PEN NEEDLES 31G - 4MM2022-03-08
00373317000026AUMMINI PEN NEEDLES 31G - 5MM2022-03-08
00373317000057AUMMINI PEN NEEDLES 31G - 6MM2022-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.FLL2026-05-27
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08698870325297FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22
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