X-Series

Basic Information

• Brand Name: X-Series
• Primary DI: 00851113007369
• Version / Model: 02-4101
• Company Name: ADVANCED BRAIN MONITORING, INC.
• Labeler DUNS: 969842715
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-27
• Public Version: 4
• Public Version Date: 2022-01-11
• Public Version Status: Update
• Public Device Record Key: 8cb776da-ec4f-4ace-81dc-7a409099caf2

Device Description

OSFA Strap

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	882.1400	2
GWQ	Full-Montage Standard Electroencephalograph	Neurology	882.1400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35709	Electrode/transducer strap, reusable	A strip of material (e.g., fabric) intended to be used to hold electrodes and/or transducers (e.g., foetal monitoring transducers) in place on the body surface; it typically has fasteners (e.g., Velcro, buckle). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10851113007366	GS1	kit of 5 headbands	5	In Commercial Distribution
Primary	00851113007369	GS1

Premarket Submissions

Submission Number	Supplement Number
K131383	000