AccessGUDID - DEVICE: RenewTM NCP-5 External Counterpulsation System (08883000001640)

GUDID

Device Identifier (DI) Information

Brand Name: RenewTM NCP-5 External Counterpulsation System
Version or Model: NCP-5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 21944
Company Name: RENEW GROUP PRIVATE LIMITED

Primary DI Number: 08883000001640
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 659209795 *Terms of Use

Device Description: EXTERNAL COUNTERPULSATION SYSTEM

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?
61283	External counterpulsation system, mobile	A noninvasive, mobile 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 an air pump with inflatable cuffs, ECG cables, a control unit or software for use with a personal computer (PC), and 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 [?]
K152115	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 45 and 105 KiloPascal
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -15 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e70269c2-d9b9-4bf1-8d28-3ae840bfaca4
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: March 15, 2017