ECP PSK

GUDID 06971379470012

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

External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile External counterpulsation system, mobile

• Primary Device ID: 06971379470012
• NIH Device Record Key: abc380ee-e03b-4e17-9eca-23cd534e6e3f
• Commercial Distribution Discontinuation: 2020-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECP PSK
• Version Model Number: P-ECP/TM
• Company DUNS: 527142177
• Company Name: Chongqing PSK-Health Sci-Tech Development Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971379470012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130439

FDA Product Code

• DRN: Device, Counter-Pulsating, External

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-30
• Device Publish Date: 2017-12-04

On-Brand Devices [ECP PSK]

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