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BRAEBON SpO2 Cable for MediByte, Small Soft Shell

FDA UDIEUDAMED

Class II (US FDA UDI)

by Braebon Medical Corp.

Identity

Trade Name
BRAEBON SpO2 Cable for MediByte, Small Soft Shell 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
8895 FDA UDI
Description
Silicon finger probe for measuring blood oxygen saturation. Plugs directly into the MediByte. FDA UDI

Identifiers

Catalog Number
8895 FDA UDI
Primary DI / UDI-DI
B14088950 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, Small Soft Shell by Braebon Medical Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Pulse oximeter probe, reusable.

Cleared under the same submission

K061764 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Braebon Medical Corp.

Sources (2)

  • FDA UDI 2488fc7b-250b-44d4-a578-f71e94337b21 37 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 4, 2026