AccessGUDID - DEVICE: PSK, Air-bag Type Sequential External Counter-pulsation Device (06971379470074)

GUDID

Device Identifier (DI) Information

Brand Name: PSK, Air-bag Type Sequential External Counter-pulsation Device
Version or Model: PECP/TM
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Chongqing PSK-Health Sci-Tech Development Co.,Ltd.

Primary DI Number: 06971379470074
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 527142177 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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):	No
Over the Counter (OTC):	Yes
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 [?]
K130439	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f512d903-0eaa-410d-a3de-e3db97bd4954
Public Version Date: April 23, 2025
Public Version Number: 1
DI Record Publish Date: April 15, 2025