TruSignal SpO2

GUDID 00840682103121

GE Healthcare Finland Oy

Pulse oximeter, line-powered
Primary Device ID00840682103121
NIH Device Record Key0aacec65-ff87-49f5-9cda-45c11d0f148a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTruSignal SpO2
Version Model NumberTS-W-D
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 Usefalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682103121 [Primary]

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 Date2016-06-16

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

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