Assy, Pulmo Chest Bellows, Tubing

Basic Information

• Brand Name: Assy, Pulmo Chest Bellows, Tubing
• Primary DI: 00851607003105
• Version / Model: A01A103
• 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: 427308d1-2395-4d0a-920b-33275e4fee0d

Device Description

Interactive Breath Hold Monitor - Assy, Pulmo Chest Bellows, Tubing 10'

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
56624	Breath-hold system patient belt, pneumatic	A non-sterile component of a breath-hold system that operates pneumatically and is designed to be worn around the chest or abdomen of the patient to detect movement during the respiratory cycle. It is connected to the system's base station where motion measuring devices (e.g., transducers) translate pneumatic pressures into electronic values. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851607003105	GS1
Package	10851607003102	GS1	Shipper	1	In Commercial Distribution

Customer Contacts

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