DEVICE: Nonin (00849686074086)

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Device Record History
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Device Identifier (DI) Information
Nonin
9570
In Commercial Distribution

NONIN MEDICAL, INC.
00849686074086
GS1

1
174959692 *Terms of Use
GO2 Finger Pulse Oximeter, Green
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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?
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
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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 -22 and 122 Degrees Fahrenheit
Storage Environment Temperature: between -30 and 50 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Infant
Device Size Text, specify: Pediatric
Device Size Text, specify: Adult
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Device Record Status
c15786c4-7022-4561-8151-f52863a152f6
November 10, 2021
5
August 24, 2016
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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
00833166001556 1 00849686074086 In Commercial Distribution Clamshell
00849686075205 1 00849686074086 In Commercial Distribution Clamshell
00833166001884 1 00849686074086 In Commercial Distribution Clamshell
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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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
763 553 9968
Regulatory@nonin.com
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