Forehead SpO2 Sensor
Nellcor - RS10
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
- Greater than, 40, kg;
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 30884522042523
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 20884522042526
Package Quantity: 3
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
Device Id: 10884522042529
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
Device Id: 20884522042526
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10884522042529
Package Quantity: 6
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: PACK_OR_INNER_PACK