EXCOR® VAD

Basic Information

• Brand Name: EXCOR® VAD
• Primary DI: 04260090040225
• Version / Model: D03I-111
• Company Name: Berlin Heart GmbH
• Labeler DUNS: 328654384
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-24
• Public Version: 6
• Public Version Date: 2022-10-05
• Public Version Status: Update
• Public Device Record Key: 0ad2920e-9768-4958-990f-5a32b72d19b9

Device Description

Stationary Driving Unit Ikus Rev. 2.1

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DSQ	Ventricular (Assisst) Bypass	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
10847	External ventricular circulatory assist system	An assembly of devices intended to assist a damaged or weakened heart (e.g., one affected by cardiogenic shock) to pump blood. It includes a mains electricity (AC-powered) external pump, an atrial or ventricular cannula to draw blood outside the body, a cannula to deliver the blood back to the aorta or pulmonary artery (depending on left or right ventricular assistance), and a unit that controls pump operation. It is typically intended to be used as a bridge to heart transplantation; it is not intended for cardiopulmonary bypass.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260090040225	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
H100004	003
H100004	004
H100004	006
H100004	007
H100004	008
H100004	009
H100004	013
H100004	016
H100004	021
P160035	000
P160035	001
P160035	005
P160035	006
P160035	008
P160035	012
P160035	015
P160035	016
P160035	020
P160035	022
P160035	026
P160035	028

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 45 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 78 – 101 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: -10 – 50 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius