DIAGNOSTIX Pulse Oximeter,Fingertip, Adult

DIAGNOSTIX Pulse Oximeter,Fingertip, Adult
Diagnostix™ - 2100

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.

• Finger Thickness .31 to .79 inches.

Device Sterile: False

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: 00634782561888

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00634782861889

Package Quantity: 25

Package Discontinue Date: 9/30/2023 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Master Case

Device Id: 00634782861889

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00634782062088

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Inner pack

Device Id: 00634782062088

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: 00634782500214

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00634782861889

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Master Case