ECP PSK

GUDID 06971379470012

Chongqing PSK-Health Sci-Tech Development Co.,Ltd.

External counterpulsation system, mobile
Primary Device ID06971379470012
NIH Device Record Keyabc380ee-e03b-4e17-9eca-23cd534e6e3f
Commercial Distribution Discontinuation2020-12-31
Commercial Distribution StatusIn Commercial Distribution
Brand NameECP PSK
Version Model NumberP-ECP/TM
Company DUNS527142177
Company NameChongqing PSK-Health Sci-Tech Development Co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106971379470012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRNDevice, Counter-Pulsating, External

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-30
Device Publish Date2017-12-04

On-Brand Devices [ECP PSK]

06971379470029P-ECP/TI
06971379470012P-ECP/TM

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