TruSignal SpO2

GUDID 00840682116770

GE Healthcare Finland Oy

Pulse oximeter probe, single-use
Primary Device ID00840682116770
NIH Device Record Keye6df9f7c-cc06-498a-84e7-46441076c12b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTruSignal SpO2
Version Model NumberTS-AP
Company DUNS401966697
Company NameGE Healthcare Finland Oy
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx
Phone+1(800)558-5120
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682103220 [Primary]
GS100840682116763 [Package]
Contains: 00840682103220
Package: [10 Units]
In Commercial Distribution
GS100840682116770 [Package]
Contains: 00840682103220
Package: [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPZOximeter, ear

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-29

On-Brand Devices [TruSignal SpO2]

00840682103435TS-F4-GE
00840682103428TS-E4-GE
00840682103411TS-SP3-GE
00840682103404TS-SP-D
00840682103398TS-N3
00840682103381TS-E4-N
00840682103367TS-E4-H
00840682103343TS-F1-H
00840682103329TS-SA-D
00840682103312TS-G3
00840682116695TS-AAW
00840682103282TS-SE-3
00840682116725TS-PAW
00840682103251TS-E-D
00840682103244TS-H3
00840682103237TS-SA4-GE
00840682116770TS-AP
00840682103206TS-F-D
00840682103190TS-F4-N
00840682116749TS-AF
00840682103169TS-F4-MC
00840682103152TS-F2-GE
00840682103138TS-E2-GE
00840682103121TS-W-D
00840682103114TS-M3

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.