FDA.reportPublic FDA data

bt-degree

Primary DI
00817076010952
Brand
bt-degree
Company
MICRO CURRENT TECHNOLOGY, INC.
Model
PG-IRT1602
Device description
IR Thermometer
Published
2020-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K182597000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182597000Infrared thermometerShenzhen Pango Electronic Co., Ltd.2019-04-03FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817076010952PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817076010952008170760109528170760109520817076010952

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
121167779
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817076014516bt-sculpt GEN2MF-882025-08-06
00817076014523bt-sculpt GEN2MF-882025-08-06
00817076014530bt-sculpt GEN2MF-882025-08-06
00817076014370myCareMF-942024-08-14
00817076014219bt-sculptMF-772024-02-28
00817076010877Bio- Ultimate PlatinumULTRA2019-01-30
00817076010884bt-nanoULTRA2019-01-30
00817076010822AutoCareE275MF-192018-03-15
00817076010839HomeCareS21MF-HOMECARE2018-03-15
00817076010846CustomCareS21MF-912018-03-15
00817076010853PrecisionCareE275MF-922018-03-15
00817076010860PainCareS21MF-1052018-03-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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