ECP PSK

GUDID 06971379470029

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

External counterpulsation system, stationary

• Primary Device ID: 06971379470029
• NIH Device Record Key: 82f5f650-3f44-4fcc-9263-f3f54973484a
• Commercial Distribution Discontinuation: 2020-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECP PSK
• Version Model Number: P-ECP/TI
• 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	06971379470029 [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