FDA.reportPublic FDA data

SmartMonitor 2 w/o Modem

Primary DI
B0364002
Brand
SmartMonitor 2 w/o Modem
Company
CIRCADIANCE, LLC
Model
4002
Catalog number
4002
Device description
SmartMonitor 2 w/o Modem
Published
2015-12-02
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
FLSMonitor, Apnea, Facility Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLSMonitor, Apnea, Facility UseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011597000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011597000SMARTMONITOR 2, MODEL 4000Respironics Georgia, Inc.2002-01-11FLS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B0364002PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Infant apnoea monitorA mains electricity (AC-powered) device that is used to register the respiratory rate of an infant and which gives an alarm signal (e.g., audible/visual) when the pre-set limits are exceeded caused by an extended interruption or cessation (apnoea) of the infants breathing pattern; a condition known as sudden infant death syndrome (SIDS). This will alert the infant's parent(s), child-minder or hospital staff when such life-threatening episodes occur. This device is usually connected to some form of movement sensing device, e.g., small pads placed directly under the infant or belts with sensors around the chest. It can be designed for use in the hospital/institution, or for home-use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius45 Degrees Celsius
Special Storage Condition, Specify00Battery Charge Temperature: 10ºC to 35ºC
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius65 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-825-9640info@circadiance.com

Regulatory Flags#

DUNS number
012721295
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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B0361078537NeoPAP Bonnet - M107853710785372016-07-29
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B0361078612NeoPAP Cannula - S107861210786122016-07-29
B0361078613NeoPAP Cannula - M107861310786132016-07-29
B0361078614NeoPAP Cannula - L107861410786142016-07-29
B0361078616NeoPAP Cannula - XL107861610786162016-07-29
B0361078668NeoPAP Mask - L107866810786682016-07-29
B036100274SleepWeaver Advance - Mask & Headgear - Blue1002741002742016-09-22
B036100277SleepWeaver Advance - Mask & Headgear - Pink1002771002772016-09-22
B036100281SleepWeaver Advance - Mask & Headgear - Camo1002811002812016-09-22
B036100285SleepWeaver Advance - Mask & Headgear - Leopard1002851002852016-09-22
B036100289SleepWeaver Advance - Mask Only - Blue1002891002892016-09-20
B036100291SleepWeaver Advance - Mask Only - Pink1002911002912016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B0364003SmartMonitor 2 w/ ModemCIRCADIANCE, LLCFLS2015-12-06