FDA.reportPublic FDA data

EXCOR®

Primary DI
04260090040225
Brand
EXCOR®
Company
Berlin Heart GmbH
Model
D03I-111
Device description
Stationary Driving Unit Ikus Rev. 2.1
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSQVentricular (Assisst) Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSQVentricular (Assist) BypassUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H100004003
H100004004
H100004006
H100004007
H100004008
H100004009
H100004013
H100004016
H100004021
P160035000
P160035001
P160035005
P160035006
P160035008
P160035012
P160035015
P160035016
P160035020
P160035022
P160035026
P160035028
P160035038

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H100004003
H100004004
H100004006
H100004007
H100004008
H100004009
H100004013
H100004016
H100004021
P160035000EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035001EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035005EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035006EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035008EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035012EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035015EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035016EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035020EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035022EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035026EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035028EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035038EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260090040225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260090040225042600900402254260090040225

GMDN Terms#

Term, Definition table
TermDefinition
External ventricular circulatory assist systemAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure78 KiloPascal101 KiloPascal
Handling Environment Humidity45 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.281.863.9700info@berlinheartinc.com

Regulatory Flags#

DUNS number
328654384
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260090040010EXCOR®P50P-0012014-09-24
04260090040027EXCOR®P60P-0012014-09-24
04260090040102EXCOR®P10P-0012014-09-24
04260090040119EXCOR®P25P-001x012014-09-24
04260090040126EXCOR®P30P-001x012014-09-24
04260090040140EXCOR® A06-0062014-09-24
04260090040157EXCOR®P15P-0012014-09-24
04260090040164EXCOR®C60G-0022014-09-24
04260090040171EXCOR®A09-0092014-09-24
04260090040188EXCOR®C85G-0022014-09-24
04260090040232EXCOR® C22V-0022014-09-24
04260090040249EXCOR®A12-0122014-09-24
04260090040256EXCOR®C26V-0022014-09-24
04260090040287EXCOR®C27A-0012014-09-24
04260090040331EXCOR®C60G-0042014-09-24
04260090040348EXCOR® C85G-0042014-09-24
04260090040379EXCOR®C15V-040m2017-09-06
04260090040386EXCOR® C85G-004m2017-09-06
04260090040393EXCOR®C80G-0212014-09-24
04260090040423EXCOR®C22V-0042014-09-24

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