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BRAEBON Ultima Body Position Sensor with 2.5 mm phone connector

FDA UDI

Class II (US FDA UDI)

by Braebon Medical Corp.

Identity

Trade Name
BRAEBON Ultima Body Position Sensor with 2.5 mm phone connector FDA UDI
Generic Name
Patient positioning sensor FDA UDI
Device Name
Five-position sensor to accurately record body position during sleep studies. FDA UDI
Model / Reference
0534 FDA UDI
Description
Five-position sensor to accurately record body position during sleep studies. FDA UDI

Identifiers

Catalog Number
0534 FDA UDI
Primary DI / UDI-DI
B14005340 FDA UDI
510(k) Number
K981969 FDA UDI
FDA Product Code
LEL FDA UDI
GMDN Term
Patient positioning sensor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5050 FDA UDI
Commercial Distribution
Not 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

BRAEBON Ultima Body Position Sensor with 2.5 mm phone connector by Braebon Medical Corp. — Class II — FDA UDI — listed in FDA GUDID

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 1fe94f71-ecab-411f-b222-a8e6d0bd171b 38 fields · synced Jun 8, 2026