BRAEBON Disposable RIP Belt, Large 5573-24

GUDID B1405573241

Disposable belt intended for use during sleep disorder studies as a measure of respiratory effort for recording with a data acquisition system. The s

Braebon Medical Corporation

Pneumograph Pneumograph
Primary Device IDB1405573241
NIH Device Record Key79c96f9b-37b1-49c0-bd60-807e38d8699d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBRAEBON Disposable RIP Belt, Large
Version Model Number5573-24
Catalog Number5573-24
Company DUNS251731105
Company NameBraebon Medical Corporation
Device Count24
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone613.831.6690
Emailinfo@braebon.com
Phone613.831.6690
Emailinfo@braebon.com

Device Dimensions

Length39 Inch
Length39 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB14055730 [Unit of Use]
HIBCCB1405573241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZQMonitor, Breathing Frequency

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

On-Brand Devices [BRAEBON Disposable RIP Belt, Large]

B1405573241Disposable belt intended for use during sleep disorder studies as a measure of respiratory effo
B14055710Disposable belt intended for use during sleep disorder studies as a measure of respiratory effo

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.