DEVICE: SpO2 Sensor (20884838102655)
Device Identifier (DI) Information
SpO2 Sensor
SPO2 SPU Ped-Adlt Clip Sensor M1131A
In Commercial Distribution
989803205831
Philips Medizin Systeme Böblingen GmbH
SPO2 SPU Ped-Adlt Clip Sensor M1131A
In Commercial Distribution
989803205831
Philips Medizin Systeme Böblingen GmbH
M1131A Disposable Adult / Pediatric SpO2 Sensor
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
31658 | Pulse oximeter probe, single-use |
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DQA | Oximeter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 12 and 35 Degrees Celsius |
Storage Environment Temperature: between 53.6 and 95 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure: between 57 and 107.5 KiloPascal |
Storage Environment Humidity: between 18 and 75 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
386d4484-2ff0-4ee6-b012-ffc5d7b3e61e
May 05, 2023
7
March 18, 2021
May 05, 2023
7
March 18, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00884838102651
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(999)999-9999
xx@xx.xx
xx@xx.xx