AccessGUDID - DEVICE: Vasomedical™Lumenair™ EECP® Therapy System (00817980020788)

GUDID

Device Identifier (DI) Information

Brand Name: Vasomedical™Lumenair™ EECP® Therapy System
Version or Model: Model Lumenair
Commercial Distribution Status: In Commercial Distribution
Catalog Number: V10-0020-1
Company Name: VASOMEDICAL, INC.

Primary DI Number: 00817980020788
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 197210248 *Terms of Use

Device Description: System, Lumenair

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRN	Device, counter-pulsating, external

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K033617	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Temperature: between -10 and 60 Degrees Celsius
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7b68dc5e-a564-4e65-8308-d4a24da52e87
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 29, 2016