Stryker Sustainability Solutions

Stryker Sustainability Solutions - 4000

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. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.

No Data Available

• Length: 3.0 Inch

Device Sterile: False

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: 37613327610544

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 07613327610543

Package Quantity: 20

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: pack

Device Id: 07613327610543

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