BRAEBON 1-Foot Double Buckle Effort Belt

FDA UDI

Class II (US FDA UDI)

by Braebon Medical Corp.

Identity

Trade Name: BRAEBON 1-Foot Double Buckle Effort Belt FDA UDI
Generic Name: Electrode/transducer strap, reusable FDA UDI
Device Name: Belt for use with PVDF Respiratory effort sensor.. FDA UDI
Model / Reference: 0526-1 FDA UDI
Description: Belt for use with PVDF Respiratory effort sensor.. FDA UDI

Identifiers

Catalog Number: 0526-1 FDA UDI
Primary DI / UDI-DI: B140052610 FDA UDI
510(k) Number: K982216 FDA UDI
FDA Product Code: BZQ FDA UDI
GMDN Term: Electrode/transducer strap, 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 1 Feet FDA UDI

Category: Electrode/transducer strap, reusable Pneumograph

BRAEBON 1-Foot Double Buckle Effort Belt by Braebon Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Pneumograph.

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BRAEBON Disposable RIP Belt, Small — Braebon Medical Corp. · Class II
BRAEBON Ultima PVDF Respiratory Effort Sensor for Alice 4 — Braebon Medical Corp. · Class II
BRAEBON Disposable RIP Belt, Medium — Braebon Medical Corp. · Class II
BRAEBON Disposable RIP Belt, Large — Braebon Medical Corp. · Class II
BRAEBON Ultima PVDF Respiratory Effort Sensor for Alice 3 — Braebon Medical Corp. · Class II

Cleared under the same submission

K982216 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Braebon Medical Corp.

Sources (1)

FDA UDI 45dd0f74-617e-4377-b3b8-2e37ff9fe56e 37 fields · synced May 30, 2026