RejuvaHeart No

GUDID 00868331000409

External Counter Pulsation Device

NORTH AMERICAN ECP INC.

External counterpulsation system, stationary

• Primary Device ID: 00868331000409
• NIH Device Record Key: 527acb10-733c-454e-88af-3df5a17871b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RejuvaHeart
• Version Model Number: NCP-2
• Catalog Number: No
• Company DUNS: 080070558
• Company Name: NORTH AMERICAN ECP INC.
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 18.5 Inch
• Length: 18.5 Inch
• Length: 18.5 Inch
• Length: 18.5 Inch
• Length: 18.5 Inch
• Length: 18.5 Inch

Operating and Storage Conditions

• Handling Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius
• Handling Environment Temperature: Between 18 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868331000409 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-10-17