BRAEBON Interface Strap 0584

GUDID B14005840

Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pr

Braebon Medical Corporation

Electrode/transducer strap, reusable
Primary Device IDB14005840
NIH Device Record Key579e99d5-961d-4290-b9a0-dd942932842a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBRAEBON Interface Strap
Version Model Number0584
Catalog Number0584
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 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

Length12 Inch
Length12 Inch

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB14005840 [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

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