FDA.reportPublic FDA data

DORM DOC

Primary DI
26939663913656
Brand
DORM DOC
Company
Sejoy Biomedical Co.,Ltd.
Model
MT-111
Published
2019-12-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26939663913656PackageGS1580In Commercial Distribution
06939663913652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2693966391365626939663913656
06939663913652069396639136526939663913652

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
545241999
Device count
1
DM exempt
false
Premarket exempt
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06939663982092sejoyHCG-1012023-07-29
06939663969901SejoyBG-710b2024-12-31
16939663969908SejoyBG-710b2024-12-31
06939663911474NeulastaMT-1012016-11-22
06939663913652DORM DOCMT-1112019-12-25
06939663920759LotFancy11A-1803-I 2016-11-30
06939663922128LotFancy11A-1807-M2016-11-30
06939663922135LotFancy11A-1808-N2016-11-30
06939663924429WELBYBSP-132017-10-20
06939663924702LotFancy11C-1826-F2016-11-30
06939663924719LotFancy11C-1831-K2016-11-30
06939663924931LotFancy11A-1804-J2016-11-30
06939663925051LotFancy11C-1851-E2016-11-18
06939663925068LotFancy11C-1850-D 2016-11-14
06939663913065Family WellnessMT-46252017-04-05
06939663913072Family WellnessMT-46252017-04-05
06939663915991Family WellnessMT-1012017-04-08
06939663900034N/AMT-1012017-12-05
06939663911283Westchester MEDICAL CENTERMT-101O2017-11-04
06939663911498DORM DOCMT-1112018-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06970758502641CaremedShenzhen Caremed Medical Technology Co., Ltd.FLL2026-07-09