FDA.reportPublic FDA data

Physicians Choice

Primary DI
G018P850DC1
Brand
Physicians Choice
Company
Supply Line International Medical, LLC
Model
P850DC
Device description
Thermometer probe Cover
Published
2023-06-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
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
K211583000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211583000Infrared Thermometer, Model: HW-1Dongguan Simzo Electronic Technology Co., Ltd.2021-09-03FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G018P850DC2PackageHIBCC10In Commercial Distribution
G018P850DC3PackageHIBCC20In Commercial Distribution
G018P850DC1PrimaryHIBCC0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079241502
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G018DCC020Physicians ChoiceDCC-022022-12-09
G018DLH010Physician's ChoiceDLH012021-08-05
G018SN2301060Doctors ChoiceSN2301062021-03-25
G018SN2315060Doctors ChoiceSN2315062021-03-25
G018SN2501060Doctors ChoiceSN2501062021-03-25
G018SN2515060Doctors ChoiceSN2515062021-03-25
G018DLH012Physician's ChoiceDLH012021-08-05
G018SND25G1504Doctors ChoiceSND25G15042021-06-09
G018SND25G150401Doctors ChoiceSND25G15042021-06-09
G018SYS01LL070Doctors ChoiceSYS01072021-04-20
G018SYS01060Doctors ChoiceSYS01062021-03-25
G018SYS03060Doctors ChoiceSYS03062021-03-25
G018SN2301061Doctors ChoiceSN2301062021-03-25
G018SN2315061Doctors ChoiceSN2315062021-03-25
G018SN2501061Doctors ChoiceSN2501062021-03-25
G018SN2515061Doctors ChoiceSN2515062021-03-25
G018SYS01061Doctors ChoiceSYS01062021-03-25
G018SYS03061Doctors ChoiceSYS03062021-03-25
G018SYSR032515020Doctors ChoiceSYSR032515022021-02-03
G018SND23G01020Doctors ChoiceSND23G01022021-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970331862711TIXMORShenzhen Ruiankang Technology Co. Ltd.FLL2026-11-05
00681131280228EquateWAL-MART STORES, INC.FLL2026-11-03
09120095900816SteadyTempSteadySense GmbHFLL2026-11-03
09120095900823SteadyTempSteadySense GmbHFLL2026-11-03
00841709121746MidmarkMIDMARK CORPORATIONFLL2026-10-30
00841709121753MidmarkMIDMARK CORPORATIONFLL2026-10-30
00841709121760MidmarkMIDMARK CORPORATIONFLL2026-10-30
00841709121777MidmarkMIDMARK CORPORATIONFLL2026-10-30
00860016681507UNIVERHEALTHHangzhou Universal Electronic Co.,Ltd.FLL2026-10-28
09120095900809SteadyTempSteadySense GmbHFLL2026-10-21
06973660370520MinttiSuzhou Melodicare Medical Technology Co., Ltd.FLL2026-10-10
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyFLL2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyFLL2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyFLL2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyFLL2026-10-04
00749756389181DeRoyalDEROYAL INDUSTRIES, INC.FLL2026-09-21
00749756389204DeRoyalDEROYAL INDUSTRIES, INC.FLL2026-09-21
06944413835153Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.FLL2026-08-26
00885403523437HemoSphere AltaBecton, Dickinson And CompanyFLL2026-08-06
00885403523451HemoSphere AltaBecton, Dickinson And CompanyFLL2026-08-06
00885403523475HemoSphere AltaBecton, Dickinson And CompanyFLL2026-08-06
06970289030859foreverlittleHetaida Technology Co., LtdFLL2026-07-28
06953825911638ZKZOShenzhen Urion Technology Co., LtdFLL2026-07-23
B353UB25511UbiqVue MultiparameterLifesignals, Inc.FLL2026-07-20
06972040114334N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06972040114341N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06972040115522N/AShenzhen AOJ Medical Technology Co., LtdFLL2026-07-11
06931973457093CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09
06931973457109CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09