Home GUDID 00840682116695 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 Product Codes# Code, Name table Code Name DPZ Oximeter, ear
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DPZ Oximeter, Ear Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00840682116695 Package GS1 10 In Commercial Distribution 00840682116756 Package GS1 25 In Commercial Distribution 00840682103299 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00840682116695 00840682116695 840682116695 0840682116695 00840682116756 00840682116756 840682116756 0840682116756 00840682103299 00840682103299 840682103299 0840682103299
GMDN Terms# Term, Definition table Term Definition Pulse oximeter probe, single-use A 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 Type Low High Condition Storage Environment Humidity 5 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature -40 Degrees Celsius 60 Degrees Celsius
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 DI Brand Model Catalog Published 00195278699923 PORTRAIT MMP01 MMP01 5514246-30 2023-10-26 00195278110435 PORTRAIT MMP01 MMP01 5514246 2023-09-01 00840682103152 TruSignal SpO2 TS-F2-GE 2016-06-16 00840682147811 CARESCAPE Software 3.2 NA 2026-04-15 00195278093998 PORTRAIT HUB01 HUB01 2096437-001 2023-09-01 00198953049181 NA PiCCO Continuous Cardiac Output Cable 2026-01-05 00198953066560 NA PiCCO Injectate Sensor Cable 2026-01-05 00198953030981 PORTRAIT HSWXB V1.2 5700672-12 2025-12-10 00840682136402 NA Cardiac Output Cable, 2.4 m/8 ft. 2104180-002 2018-08-10 00840682102872 NA D-lite Spirometry Kit 2m 7ft, 8004381 2016-08-15 00840682103169 TruSignal SpO2 TS-F4-MC 2016-07-15 00840682103190 TruSignal SpO2 TS-F4-N 2016-06-16 00840682103343 TruSignal SpO2 TS-F1-H 2016-06-16 00840682103367 TruSignal SpO2 TS-E4-H 2016-06-16 00840682103381 TruSignal SpO2 TS-E4-N 2016-06-16 00840682103442 NA Pre-conf. EEG Lead Set 2 General, 898051 2016-06-16 00840682136358 NA Invasive Blood Pressure Cable, Argon, Single, 1.2 2104166-002 2018-08-10 00840682136365 NA Invasive Blood Pressure Cable, Utah/Biotrans, Sing 2104107-002 2018-08-13 00840682136464 NA Invasive Blood Pressure Cable, Utah/Biotrans, Dual 2104107-004 2018-08-10 00840682136501 NA Invasive Blood Pressure Cable, ICU Medical Transpa 2104158-004 2018-08-10
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840682147811 CARESCAPE Software GE Healthcare Finland Oy DPZ 2026-04-15 00195278984784 TruSignal SpO2 GE Healthcare Finland Oy DPZ 2025-06-16 00860008683236 OxiWear OXIWEAR, INC. DPZ 2025-06-04 05700693918808 TCM 4 series ETX base unit Radiometer Medical ApS DPZ 2025-04-23 07640121880988 103149 Calibration Gas SenTec AG DPZ 2024-07-05 07640121880995 103164 tCOM+ SenTec AG DPZ 2024-07-05 07640121881008 103420 Sensor Adapter Cable (Regular) SenTec AG DPZ 2024-07-05 07640121881015 103421 Sensor Adapter Cable (Long) SenTec AG DPZ 2024-07-05 07640121881022 103422 Sensor Adapter Cable (Extra Long) SenTec AG DPZ 2024-07-05 00195278561312 Portrait VSM Ge Medical Systems Information Technologies, Inc. DPZ 2024-05-05 07640121881039 Non-Adhesive Wrap SenTec AG DPZ 2023-07-21 17640121881036 Non-Adhesive Wrap SenTec AG DPZ 2023-07-21 00195278522313 CARESCAPE Canvas Smart Display GE Healthcare Finland Oy DPZ 2023-04-19 00195278522320 CARESCAPE Canvas 1000 GE Healthcare Finland Oy DPZ 2023-04-19 00195278523365 CARESCAPE Canvas D19 GE Healthcare Finland Oy DPZ 2023-04-19 00195278524089 NA GE Healthcare Finland Oy DPZ 2023-04-19 00195278288639 CARESCAPE ONE Ge Medical Systems Information Technologies, Inc. DPZ 2022-05-13 00840682146111 CARESCAPE B650 GE Healthcare Finland Oy DPZ 2022-05-13 00840682146135 CARESCAPE B450 GE Healthcare Finland Oy DPZ 2022-05-13 00840682146142 CARESCAPE B850 GE Healthcare Finland Oy DPZ 2022-05-13 00840682146708 NA GE Medical Systems Information Technologies, Inc. DPZ 2022-04-12 00840682146715 NA GE Medical Systems Information Technologies, Inc. DPZ 2022-04-12 00840682146791 NA GE Medical Systems Information Technologies, Inc. DPZ 2022-04-12 00840682147217 NA GE Medical Systems Information Technologies, Inc. DPZ 2022-04-12 00840682147224 NA GE Medical Systems Information Technologies, Inc. DPZ 2022-04-12 07640121880964 Patient Application Kit for mature intact skin SenTec AG DPZ 2021-09-26 07640121880971 Patient Application Kit for sensitive/fragile skin SenTec AG DPZ 2021-09-26 07640121880957 Patient Application Kit with Ear Clip for mature/intact skin SenTec AG DPZ 2021-09-26 17640121880978 Patient Application Kit for sensitive/fragile skin SenTec AG DPZ 2021-09-26 00840682147248 TruSignal SpO2 GE Healthcare Finland Oy DPZ 2021-09-03
xx.xx