Nonin

Basic Information

• Brand Name: Nonin
• Primary DI: 00849686072136
• Version / Model: LS1
• Company Name: NONIN MEDICAL, INC.
• Labeler DUNS: 174959692
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-24
• Public Version: 4
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: d5f257db-80e9-4e48-837d-5644c309ff5c

Device Description

LifeSense II Capnography/Pulse Oximeter Monitor

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	868.1400	2
DQA	Oximeter	Cardiovascular	870.2700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31339	Carbon dioxide monitor	A mains electricity (AC-powered) device intended to continuously measure the concentration of carbon dioxide (CO2) in a gas mixture through a particular method (e.g., electrochemical, infrared absorption, gas chromatographic, mass spectrometric) to determine a patient's ventilatory, circulatory, or metabolic status. It is typically used to measure end-tidal carbon dioxide (EtCO2) in expiratory gases during the administration of anaesthesia or during bedside monitoring. Commonly known as a capnograph or a capnometer, the sampling method can be "mainstream" and/or "sidestream".	No	Active
17148	Pulse oximeter, line-powered	A mains electricity (AC-powered) photoelectric device intended for the continuous transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically used bedside.	No	Obsolete
45607	Pulse oximeter	An electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00849686072136	GS1
Package	00849686075489	GS1	Box	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K063752	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 158 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius