BRAEBON Ultima Breath Sensor Interface 0510BS

GUDID B1400510BS0

Thermistor airflow sensor intended for use during sleep disorders studies as a qualitative measure of respiratory airflow for recording onto a data ac

Braebon Medical Corporation

General-purpose patient temperature probe, reusable
Primary Device IDB1400510BS0
NIH Device Record Key45924e14-5527-4e55-89da-2e4d97538523
Commercial Distribution StatusIn Commercial Distribution
Brand NameBRAEBON Ultima Breath Sensor Interface
Version Model Number0510BS
Catalog Number0510BS
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 Batchfalse
Serial Numbertrue
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

Phone6138316690
Emailinfo@braebon.com
Phone6138316690
Emailinfo@braebon.com

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 5 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB1400510BS0 [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 Ultima Breath Sensor Interface]

B1400510BS0Thermistor airflow sensor intended for use during sleep disorders studies as a qualitative measu
B1400512BS0Thermistor airflow sensor intended for use during sleep disorders studies as a qualitative measu

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