RenewTM NCP-5 External Counterpulsation System

GUDID 00865089000316

S2 Equipment LLC

External counterpulsation system, mobile

• Primary Device ID: 00865089000316
• NIH Device Record Key: 9f2d3742-12f5-46fb-8257-91c26bb8eff9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RenewTM NCP-5 External Counterpulsation System
• Version Model Number: NCP-5
• Company DUNS: 084717183
• Company Name: S2 Equipment LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 248-987-7848
• Email: customerfeedback@renewecpusa.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 45 KiloPascal and 105 KiloPascal
• Handling Environment Atmospheric Pressure: Between 45 KiloPascal and 105 KiloPascal
• Handling Environment Atmospheric Pressure: Between 45 KiloPascal and 105 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865089000316 [Primary]

FDA Product Code

• DRN: Device, Counter-Pulsating, External

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-26
• Device Publish Date: 2018-06-25