FDA.reportPublic FDA data

TruSignal SpO2

Primary DI
00840682147286
Brand
TruSignal SpO2
Company
GE Healthcare Finland Oy
Model
TS-HB-3
Catalog number
TS-HB-3
Device description
Replacement Headband for TruSignal Ear sensor, 3 pcs
Published
2021-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DPZOximeter, ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPZOximeter, EarCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040831000
K093881000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040831000DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500Datex-Ohmeda, Inc.2004-09-02DPZ
K093881000TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSORGE Healthcare Finland Oy2010-03-12DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682147286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682147286008406821472868406821472860840682147286

GMDN Terms#

Term, Definition table
TermDefinition
Electrode/transducer strap, reusableA strip of material (e.g., fabric) intended to be used to hold electrodes and/or transducers (e.g., foetal monitoring transducers) in place on the body surface; it typically has fasteners (e.g., Velcro, buckle). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
401966697
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195278699923PORTRAIT MMP01MMP015514246-302023-10-26
00195278110435PORTRAIT MMP01MMP0155142462023-09-01
00840682103152TruSignal SpO2TS-F2-GE2016-06-16
00840682147811CARESCAPE Software3.2NA2026-04-15
00195278093998PORTRAIT HUB01HUB012096437-0012023-09-01
00198953049181NAPiCCO Continuous Cardiac Output Cable2026-01-05
00198953066560NAPiCCO Injectate Sensor Cable2026-01-05
00198953030981PORTRAIT HSWXBV1.25700672-122025-12-10
00840682136402NACardiac Output Cable, 2.4 m/8 ft.2104180-0022018-08-10
00840682102872NAD-lite Spirometry Kit 2m 7ft, 80043812016-08-15
00840682103169TruSignal SpO2TS-F4-MC2016-07-15
00840682103190TruSignal SpO2TS-F4-N2016-06-16
00840682103343TruSignal SpO2TS-F1-H2016-06-16
00840682103367TruSignal SpO2TS-E4-H2016-06-16
00840682103381TruSignal SpO2TS-E4-N2016-06-16
00840682103442NAPre-conf. EEG Lead Set 2 General, 8980512016-06-16
00840682136358NAInvasive Blood Pressure Cable, Argon, Single, 1.2 2104166-0022018-08-10
00840682136365NAInvasive Blood Pressure Cable, Utah/Biotrans, Sing2104107-0022018-08-13
00840682136464NAInvasive Blood Pressure Cable, Utah/Biotrans, Dual2104107-0042018-08-10
00840682136501NAInvasive Blood Pressure Cable, ICU Medical Transpa2104158-0042018-08-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyDPZ2026-04-15
00195278984784TruSignal SpO2GE Healthcare Finland OyDPZ2025-06-16
00860008683236OxiWearOXIWEAR, INC.DPZ2025-06-04
05700693918808TCM 4 series ETX base unitRadiometer Medical ApSDPZ2025-04-23
07640121880988103149 Calibration GasSenTec AGDPZ2024-07-05
07640121880995103164 tCOM+SenTec AGDPZ2024-07-05
07640121881008103420 Sensor Adapter Cable (Regular)SenTec AGDPZ2024-07-05
07640121881015103421 Sensor Adapter Cable (Long)SenTec AGDPZ2024-07-05
07640121881022103422 Sensor Adapter Cable (Extra Long)SenTec AGDPZ2024-07-05
00195278561312Portrait VSMGe Medical Systems Information Technologies, Inc.DPZ2024-05-05
07640121881039Non-Adhesive WrapSenTec AGDPZ2023-07-21
17640121881036Non-Adhesive WrapSenTec AGDPZ2023-07-21
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyDPZ2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyDPZ2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyDPZ2023-04-19
00195278524089NAGE Healthcare Finland OyDPZ2023-04-19
00195278288639CARESCAPE ONEGe Medical Systems Information Technologies, Inc.DPZ2022-05-13
00840682146111CARESCAPE B650GE Healthcare Finland OyDPZ2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyDPZ2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyDPZ2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.DPZ2022-04-12
00840682146715NAGE Medical Systems Information Technologies, Inc.DPZ2022-04-12
00840682146791NAGE Medical Systems Information Technologies, Inc.DPZ2022-04-12
00840682147217NAGE Medical Systems Information Technologies, Inc.DPZ2022-04-12
00840682147224NAGE Medical Systems Information Technologies, Inc.DPZ2022-04-12
07640121880964Patient Application Kit for mature intact skinSenTec AGDPZ2021-09-26
07640121880971Patient Application Kit for sensitive/fragile skinSenTec AGDPZ2021-09-26
07640121880957Patient Application Kit with Ear Clip for mature/intact skinSenTec AGDPZ2021-09-26
17640121880978Patient Application Kit for sensitive/fragile skinSenTec AGDPZ2021-09-26
00840682147248TruSignal SpO2GE Healthcare Finland OyDPZ2021-09-03