MasimoSET® LNOP® TC-I SpO2 Reusable Ear Sensor

GUDID 00843997000239

Pulse oximeter probe, reusable

Primary Device ID	00843997000239
NIH Device Record Key	8d5f8e63-d9e0-4b8e-a480-2a65caa954b4
Commercial Distribution Status	In Commercial Distribution
Brand Name	MasimoSET® LNOP® TC-I SpO2 Reusable Ear Sensor
Version Model Number	1794
Company DUNS	780421038
Company Name	MASIMO CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00843997000239 [Primary]

DPZ	Oximeter, ear

Steralize Prior To Use	false
Device Is Sterile	false

00843997016896 - NomoLine	2025-06-02 NomoLine ISA OR+
00843997016919 - NomoLine	2025-06-02 NomoLine ISA AX+
00843997016544 - Nomoline	2025-04-09 NomoLine ISA OR+
00843997017640 - Stork	2024-11-08 Stork Hub
00843997017589 - Stork	2024-11-08 Stork Sensor
00843997016551 - Home Health Kit	2024-09-17 Home Health Kit
00843997017442 - Radius PPG	2024-09-17 Masimo SafetyNet, Radius PPG Chip
00843997009065 - Radius VSM	2024-08-27 Radius VSM Multi-functional Reusable Pod, 1/Box