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
20884838102655
GS1

20
314101143 *Terms of Use
M1131A Disposable Adult / Pediatric SpO2 Sensor
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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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DQA Oximeter
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
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
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

386d4484-2ff0-4ee6-b012-ffc5d7b3e61e
May 05, 2023
7
March 18, 2021
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 00884838102651 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(999)999-9999
xx@xx.xx
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