SmartMonitor 2 w/ Modem

Basic Information

• Brand Name: SmartMonitor 2 w/ Modem
• Primary DI: B0364003
• Version / Model: 4003
• Catalog Number: 4003
• Company Name: CIRCADIANCE, LLC
• Labeler DUNS: 012721295
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-12-06
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: e89e13e9-c75c-4055-9292-0d04e6826d9d

Device Description

SmartMonitor 2 w/ Modem

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FLS	Monitor, Apnea, Facility Use	Anesthesiology	868.2377	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36319	Infant apnoea monitor	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B0364003	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K011597	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Battery Charge Temperature: 10ºC to 35ºC
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 65 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 20 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 5 – 45 Degrees Celsius