Nonin

Basic Information

• Brand Name: Nonin
• Primary DI: 00849686072181
• Version / Model: LS1-9R
• 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: 5
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: 4ab6353a-cad8-4314-b4fc-79044d4d1c76

Device Description

LifeSense Capnography/Pulse Oximeter Monitor

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
Package	00849686088106	GS1	Box	1	In Commercial Distribution
Primary	00849686072181	GS1

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