DEVICE: Oxxiom (B944TWPD1DA0320150)

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Device Record History
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Device Identifier (DI) Information
Oxxiom
1612
In Commercial Distribution
TWPD1DA032015
TRUE WEARABLES, INC.
B944TWPD1DA0320150
HIBCC

1
080108600 *Terms of Use
Wireless, Disposable, Single-Use Pulse Oximetry System
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Device Characteristics
MR Unsafe
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?
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 [?]
K200537 000
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 15 and 30 Degrees Celsius
Handling Environment Temperature: between 5 and 40 Degrees Celsius
Handling Environment Humidity: less than 95 Percent (%) Relative Humidity
Storage Environment Humidity: less than 60 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
ce4ac030-2c01-4bb9-8a2a-b0ae9fe89f23
November 10, 2021
2
December 10, 2020
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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: 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
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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