FDA.reportPublic FDA data

BRAEBON Alice Interface Cable for 0580D

Primary DI
B14005930
Brand
BRAEBON Alice Interface Cable for 0580D
Company
Braebon Medical Corporation
Model
0593
Catalog number
0593
Device description
Cable for connecting sensors to a device.
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K984431000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K984431000ULTIMA AIRFLOW PRESSURE SENSORBraebon Medical Corp.1998-12-30BZQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B14005930PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter12Inch

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
613.831.6690info@braebon.com

Regulatory Flags#

DUNS number
251731105
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B1400580A1BRAEBON PT1 Low Gain/ Hi Pressure Transducer Kit for Alice0580A0580A2026-03-06
B1400580D1BRAEBON PT2 Dual Differntial Airflow Pressure Kit0580D0580D2026-03-06
B1400580N1BRAEBON Ultima Airflow Pressure Kit0580N0580-NOX2026-03-06
B1400580PES1BRAEBON Ultima Esophageal Pressure Transducer0580PES0580PES2026-03-06
B1400580AXA0BRAEBON PT1 Low Gain/ Hi Pressure Transducer Kit for Alice0580A0580A2025-04-30
B1400582501Ultima Nasal Cannula + Filter0582-500582-502019-10-25
B1400580D0BRAEBON PT2 Dual Differntial Airflow Pressure Kit0580D0580D2016-09-22
B1400580PES0BRAEBON Ultima Esophageal Pressure Transducer0580PES0580PES2016-09-22
B1408111251MediByte Patient Kit8111-258111-252025-05-02
B14081110MediByte Patient Kit8111-258111-252025-05-02
B14085990Oral + Nasal Cannula with Filter859985992025-05-02
B14003760BRAEBON Interface Cable for Alice 6037603762025-04-30
B140MDO0BRAEBON MediOXMD-OMD-O2025-04-28
B140MDOK0BRAEBON MediByte Jr. KitMDO-KMDO-K2025-04-28
B1400580A0BRAEBON PT2 Dual Differntial Airflow Pressure Kit for Alice0580A0580A2016-09-22
B1408130201MediByte Electrode Prep Kit8130-208130-202019-11-08
B140BM5598501Divided Nasall Cannula + Filter, PediatricBM5598-50BM5598-502019-11-08
B1400582MCO2501Ultima Divided Nasal Cannula + Filter0582MCO2-500582MCO2-502019-10-25
B1400582MCO2PED501Ultima Divided Nasal Cannula + Filter, Pediatric0582MCO2-PED-500582MCO2-PED-502019-10-25
B14086201201BRAEBON Leadwire Kit8620-1208620-1202024-09-13

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