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BRAEBON SpO2 Cable for MediByte, Medium

FDA UDI

Class II (US FDA UDI)

by Braebon Medical Corp.

Identity

Trade Name
BRAEBON SpO2 Cable for MediByte, Medium FDA UDI
Generic Name
Pulse oximeter probe, reusable FDA UDI
Device Name
Silicon finger probe for measuring blood oxygen saturation. Plugs directly into the MediByte. FDA UDI
Model / Reference
8897 FDA UDI
Description
Silicon finger probe for measuring blood oxygen saturation. Plugs directly into the MediByte. FDA UDI

Identifiers

Catalog Number
8897 FDA UDI
Primary DI / UDI-DI
B14088970 FDA UDI
510(k) Number
K061764 FDA UDI
FDA Product Code
MNR FDA UDI
GMDN Term
Pulse oximeter probe, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.2375 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Pulse oximeter probe, reusable

BRAEBON SpO2 Cable for MediByte, Medium by Braebon Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pulse oximeter probe, reusable.

Cleared under the same submission

K061764 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Braebon Medical Corp.

Sources (1)

  • FDA UDI e4c9458c-9deb-4639-a1d6-995222b63b78 37 fields · synced Jun 1, 2026