DEVICE: Nonin (00849686074710)
Device Identifier (DI) Information
Nonin
2500A
In Commercial Distribution
NONIN MEDICAL, INC.
2500A
In Commercial Distribution
NONIN MEDICAL, INC.
2500A Handheld Pulse Oximeter with Alarms
Device Characteristics
| MR Unsafe | |
| No | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 17148 | Pulse oximeter, line-powered |
A mains electricity (AC-powered) photoelectric device intended for the continuous transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically used bedside.
|
Obsolete | false |
| 45607 | Pulse oximeter |
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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| DQA | Oximeter |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K050056 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between -40 and 158 Degrees Fahrenheit |
| Storage Environment Temperature: between -40 and 70 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
2695b174-e4f1-4f48-8430-50286aaa32f8
November 10, 2021
4
September 06, 2016
November 10, 2021
4
September 06, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 00849686090178 | 1 | 00849686074710 | In Commercial Distribution | Box | |
| 00833166000016 | 1 | 00849686074710 | In Commercial Distribution | Box | |
| 00849686067743 | 1 | 00849686074710 | In Commercial Distribution | Box |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
763 553 9968
Regulatory@nonin.com
Regulatory@nonin.com