Monitor System, IBC Base Unit

Basic Information

• Brand Name: Monitor System, IBC Base Unit
• Primary DI: 00851607003136
• Version / Model: 43T2631
• Company Name: MEDSPIRA, LLC
• Labeler DUNS: 962187964
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-09
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: d1d3406f-0188-4c6e-91b1-1c01ac8f8be8

Device Description

Interactive Breath Hold - Monitor System, IBC Base Unit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
HCC	Device, Biofeedback	Neurology	882.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56622	Breath-hold system base station	A battery-powered component of a breath-hold system designed to electronically receive a patient's mechanical respiratory movements, detected by a patient belt, convert these to electronic values and wirelessly transmit signals to a remote display that is viewed by the patient for instruction on when and how long to hold their breath. This device may also function as a holder and a charger for multiple remote displays when connected to the main electrical supply.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10851607003133	GS1	Shipper	5	In Commercial Distribution
Primary	00851607003136	GS1

Customer Contacts

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