Bladder Set, Medium

Basic Information

• Brand Name: Bladder Set, Medium
• Primary DI: 00817980021099
• Version / Model: Model Lumenair
• Catalog Number: V23-0011
• Company Name: VASOMEDICAL, INC.
• Labeler DUNS: 197210248
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-29
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: b19c9678-699d-4b45-9ff7-9b0db6b9c923

Device Description

Bladder Set, Medium

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: No
• PM Exempt: No
• Has Serial Number: No
• 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
DRN	Device, counter-pulsating, external	Cardiovascular	870.5225	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61282	External counterpulsation system, stationary	A noninvasive, stationary assembly of devices intended to assist the blood circulation of an adult patient suffering from heart disease through the electrocardiogram (ECG) synchronized inflation of pressure cuffs worn around the extremities/buttocks. It includes a patient bed with inflatable cuffs, an air pump, ECG cables, and either a control unit or software for use with a personal computer (PC); it may include a pulse oximeter probe. The cuffs are intended to inflate from the most distal to the most proximal during diastole and deflate during systole to increase preload/decrease afterload. The system is intended to be operated by a professional in a clinical setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817980021099	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K033617	000