FDA.reportPublic FDA data

Level 1

Primary DI
30695085000116
Brand
Level 1
Company
ICU MEDICAL, INC.
Model
STS-400
Published
2016-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
K864195000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K864195000SURFACE SKIN TEMP PROBE W/THERMOCOUPLE TYPE TRespiratory Support Products, Inc.1986-11-19FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10695085000112PackageGS120In Commercial Distribution
20695085000119PackageGS1200In Commercial Distribution
30695085000116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1069508500011210695085000112
2069508500011920695085000119
3069508500011630695085000116

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709208497BivonaFT26KN35NGE032N2026-11-05
10887709208503BivonaFT26KN35NSF033N2026-11-05
10887709208510BivonaST26KN80NSB035N2026-11-05
10887709208527BivonaFT26KN40NGF031N2026-11-05
10887709208572BivonaFT26KN50NGF039N2026-11-05
10887709208589BivonaST26KN80NSC040N2026-11-05
10887709208596BivonaXT26HS70NSC038N2026-11-05
10887709208602BivonaFT26KN55NGC034N2026-11-05
10887709208206BivonaHU26JS55NSB221N2026-11-04
10887709208213BivonaFT26JN40NSF243N2026-11-04
10887709208282BivonaFU26KN30NGA012N2026-11-03
10887709208299BivonaFT26KN50NGF011N2026-11-03
10887709208305BivonaFT26KN50NSC004N2026-11-03
10887709208312BivonaFT26KN40NSF007N2026-11-03
10887709208329BivonaFT26KN40NGE003S2026-11-03
10887709208336BivonaFT26KN30NGE013N2026-11-03
10887709208343BivonaXT26JS50NGC230N2026-11-03
10887709208350BivonaFU26KN35NSF018N2026-11-03
10887709208367BivonaFU26KN30NSF019N2026-11-03
10887709208374BivonaFT26KN45NGF017N2026-11-03

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