Neonatal-Adult SpO2 Sensor;OxiMax (TM) Technology

Neonatal
Nellcor OxySoft - OxySoftNHC

A photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. The is a single-use device.

• Weight, less than 3 or greater than 40, kg;

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DQA

Device Name: Oximeter

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: AN

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.2700

Third Party Flag: N

Medical Specialty: CV

Device Id: 20884521818993

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521818996

Package Quantity: 20

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

Device Id: 10884521818996

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A