BRAEBON Cable for Disposable RIP 8579

GUDID B14085790

Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a measure of respiratory effort for recording with a MediByt

Braebon Medical Corporation

Electrical-only medical device connection cable, reusable
Primary Device IDB14085790
NIH Device Record Keye4e4015d-b31c-446b-a9d8-2907c83decc5
Commercial Distribution StatusIn Commercial Distribution
Brand NameBRAEBON Cable for Disposable RIP
Version Model Number8579
Catalog Number8579
Company DUNS251731105
Company NameBraebon Medical Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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

Length14 Inch
Length14 Inch

Operating and Storage Conditions

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
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB14085790 [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 Cable for Disposable RIP]

B14085790Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a meas
B14005790Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a meas
B14085780Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a meas
B14005780Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a meas
B14005670Cable for Disposable RIP Belt which is intended for use during sleep disorder studies as a meas

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