Sleep Profiler

Basic Information

• Brand Name: Sleep Profiler
• Primary DI: 00851113007239
• Version / Model: SP40-4305
• Company Name: ADVANCED BRAIN MONITORING, INC.
• Labeler DUNS: 969842715
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2023-06-09
• Public Version Status: Update
• Public Device Record Key: 6adf1cfc-5ec2-4f07-bc0d-46a9beba3175

Device Description

50-Night Study Kit - Sleep Profiler

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	882.1400	2
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	882.1400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11467	Electroencephalograph	An electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders, and/or assist in localizing tumours or lesions on or near the surface of the brain. It is designed to acquire electrical signals from electrodes typically attached to the scalp and ear lobes. The results may be displayed via print-out or electronically; data interpretation and/or telemetry features may also be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851113007239	GS1

Premarket Submissions

Submission Number	Supplement Number
K120447	000
K130013	000
K152040	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 32 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 10 – 32 Degrees Celsius