FDA.reportPublic FDA data

TruSignal SpO2

Primary DI
00840682116695
Brand
TruSignal SpO2
Company
GE Healthcare Finland Oy
Model
TS-AAW
Published
2016-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040831000DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500Datex-Ohmeda, Inc.2004-09-02DPZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682116695PackageGS110In Commercial Distribution
00840682116756PackageGS125In Commercial Distribution
00840682103299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682116695008406821166958406821166950840682116695
00840682116756008406821167568406821167560840682116756
00840682103299008406821032998406821032990840682103299

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, single-useA photoelectric device applied externally to a body site, e.g., a fingertip, ear lobe, the bridge of nose, a toe, or the bridge of the foot of a paediatric or adult patient for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using light detection. The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector, are received by an oximeter to which this device is connected. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., electrocardiogram (ECG). The is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)558-5120xx@xx.xx

Regulatory Flags#

DUNS number
401966697
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
false
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
00840682103022OxyTip SpO2OXY-FMR-002016-06-16
00840682103077OxyTip SpO2OXY-WMR-002016-06-16
00195278949752TruSignal SpO2 MM 3.0M159769772026-10-04
00195278949769TruSignal SpO2 MM 1.8M159560152026-10-04
00198953002186Carescape Dock F0157006022026-10-04
00840682106498Mobile CareWeb Viewer2016-06-21
00198953009567Carescape ONE259560312026-10-04
00840682102957EntropyGE Entropy sensor, M10386812016-08-15
00840682102971EntropyEasyFit sensor, M11744132016-08-15
00840682102964EntropyEntropy Cable, M1050784M10507842016-06-30
00840682103015NAPiCCO Injectate Sensor Cable2016-06-10
00840682103039NAPiCCO Continuous Cardiac Output Cable2016-06-16
00840682102841NAD-Lite Spirometry Kit 3m/10ft, 80043822016-08-15
00840682102858NAPedi-Lite Spirometry Kit 3m, M10326342016-08-15
00840682102865NAPedi-lite Spirometry Kit 2m, 80027182016-08-15
00840682102926NAMini D-fend Water Trap, 800217480021742016-08-12
00840682102896NACalibration Gas, 7555872016-06-10
00840682102902NACalibration Gas, 755571-HEL2016-06-10
00198953049181NAPiCCO Continuous Cardiac Output Cable2026-01-05
00195278697165PORTRAIT HSWXBHSWXB5700219-112024-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDPZ2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDPZ2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDPZ2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDPZ2026-10-04
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