FDA.reportPublic FDA data

BRAEBON Disposable RIP Belt, Large

Primary DI
B1405576241
Brand
BRAEBON Disposable RIP Belt, Large
Company
Braebon Medical Corporation
Model
5576-24
Catalog number
5576-24
Device description
Disposable belt intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The sensor uses respiratory inductance plethysmography (RIP) technology and plugs directly into an electrode headbox or a DC amplifier.
Published
2022-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZQMonitor, Breathing Frequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZQMonitor, Breathing FrequencyAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001743000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001743000ULTIMA SMARTBELT, MODEL 0560Braebon Medical Corp.2000-08-25BZQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B1405576241PrimaryHIBCC0
B14055710Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
PneumographA device designed to graphically display chest movement during the respiratory cycle. It uses a sensor, e.g. Electrical impedance, to detect and transduce respiratory chest movement and may display both the rate and waveform of the movement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length40Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
613.831.6690info@braebon.com

Regulatory Flags#

DUNS number
251731105
Device count
24
Lot or batch
true
Manufacturing date on label
true

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