Interactive Breath Hold Monitor

Basic Information

• Brand Name: Interactive Breath Hold Monitor
• Primary DI: 00851607003082
• Version / Model: IBC01
• Catalog Number: 43T0970
• 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: 41b65461-3234-49f6-a2aa-d6e44a960713

Device Description

Interactive Breath Hold Monitor

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
56621	Breath-hold system	An assembly of portable electronic devices designed to provide bio-feedback to a patient to indicate when they should hold their breath during a procedure requiring precise location of target tissues potentially compromised by respiratory motion. It typically consists of a base station, multiple remote (wireless) displays that provide feedback to the patient and healthcare staff, patient respiration belts, and software. It is used for image-guided biopsy procedures, radio-frequency (RF) ablation, cryoablation, marker introduction, and often in conjunction with radiological systems, e.g., computed tomography (CT) and/or imaging ultrasound (US).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10851607003089	GS1	Shipper	1	In Commercial Distribution
Primary	00851607003082	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Product should be kept dry
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity