FDA.reportPublic FDA data

BRAEBON Ultima Body Position Sensor

Primary DI
B14005320
Brand
BRAEBON Ultima Body Position Sensor
Company
Braebon Medical Corporation
Model
0532
Catalog number
0532
Device description
Five-position sensor to accurately record body position during sleep studies.
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LELDevice, Sleep Assessment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LELDevice, Sleep AssessmentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981969000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981969000ULTIMA BODY POSITION SENSORBraebon Medical Corp.1998-08-20LEL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B14005320PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Patient positioning sensorA device designed to detect and respond to movement and transmits a signal proportional to the degree of motion. A parent device will receive these signals and show the position of the sensor and the object to which it is attached and make the necessary display/control adjustments for the object being monitored. It may be permanently attached to an electrical cable that relays energy to the sensor and signals back to the parent device. It may be affixed to the leg of a patient during computer assisted surgery (CAS) for implantation of a hip prosthesis to assist in the correct positioning of the implant or as a component of an electromagnetic device tracking system. This is a reusable device.

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
Serial number
true
Manufacturing date on label
true

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