DEVICE: Solaris (06900234100085)

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Device Record History
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Device Identifier (DI) Information
Solaris
T200A-090101
In Commercial Distribution

Solaris Medical Technology, Inc.
06900234100085
GS1

1
527945351 *Terms of Use
BCI Compatible Adult SpO2 Soft-Finger Sensor (0.9m cable)
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
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?
37808 Pulse oximeter probe, reusable
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. This is a reusable 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 [?]
K100077 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
644f68d8-4232-4acf-8dcb-eb84c5a4fd29
November 10, 2021
5
November 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
56900234100080 80 06900234100085 In Commercial Distribution
46900234100083 60 06900234100085 In Commercial Distribution
36900234100086 40 06900234100085 In Commercial Distribution
26900234100089 32 06900234100085 In Commercial Distribution
16900234100082 20 06900234100085 In Commercial Distribution
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Secondary DI

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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

[?]
Yes
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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