DEVICE: BV Medical (00845821012401)

Device Identifier (DI) Information

BV Medical
50-102-003-L
In Commercial Distribution

BV Medical
00845821012401
GS1

1
105932508 *Terms of Use
Pediatric Finger Pulse Oximeter with Hard Plastic Case
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Device Characteristics

MR Unsafe
No
Yes
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
18124 Oxygen saturation/pulse rate electronic-signal simulator
An electronic instrument designed to simulate arterial oxygen saturation and/or pulse rate for testing and calibrating pulse oximeters, pulse oximeter probes and other related pulse oximetry devices.
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 [?]
K063641 000
No CLOSE

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

f45d0687-b057-418e-80a1-93f9c3963c14
November 10, 2021
5
December 23, 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
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
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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