Infant SpO2 Sensor,Remanufactured,Reprocessed device for single use; Reprocessed by Covidien llc

Infant SpO2 Sensor,Remanufactured,Reprocessed device for single use; Reprocessed by Covidien llc
Nellcor - MAXIR

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.

No Data Available

• Patient Weight, 3-20, KG;

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NLF

Device Name: Oximeter, Reprocessed

Device Class: 2

Physical State: N/A

Definition: same as DQA except reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

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: Y

Medical Specialty: CV

Device Id: 10884522040891

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 20884522040898

Package Quantity: 24

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

Device Id: 20884522040898

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