TruSignal SpO2

GUDID 00840682103435

GE Healthcare Finland Oy

Pulse oximeter, line-powered

• Primary Device ID: 00840682103435
• NIH Device Record Key: 1ed5d24a-744e-42b0-af01-0a2475cf8f3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruSignal SpO2
• Version Model Number: TS-F4-GE
• Company DUNS: 401966697
• Company Name: GE Healthcare Finland Oy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)558-5120
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682103435 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043551

FDA Product Code

• MHX: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-16

On-Brand Devices [TruSignal SpO2]

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