FDA.reportPublic FDA data

EXCOR®

Primary DI
04260090040102
Brand
EXCOR®
Company
Berlin Heart GmbH
Model
P10P-001
Device description
Blood pump PU valves; 10 mL in/out; Ø 6 mm
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
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
H100004008
H100004010
H100004012
H100004013
H100004014
H100004017
H100004020
H100004021
P160035000
P160035001
P160035003
P160035004
P160035007
P160035009
P160035010
P160035011
P160035013
P160035014
P160035016
P160035017
P160035019
P160035021
P160035023
P160035024
P160035027
P160035030
P160035034
P160035035
P160035036
P160035037

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H100004003
H100004004
H100004006
H100004008
H100004010
H100004012
H100004013
H100004014
H100004017
H100004020
H100004021
P160035000EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035001EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035003EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035004EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035007EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035009EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035010EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035011EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035013EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035014EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035016EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035017EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035019EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035021EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035023EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035024EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035027EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035030EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035034EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035035EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035036EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ
P160035037EXCOR Pediatric Ventricular Assist DeviceBerlin Heart, Inc.2017-06-06DSQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260090040102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260090040102042600900401024260090040102

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume10Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity35 Percent (%) Relative Humidity50 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius25 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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260090040010EXCOR®P50P-0012014-09-24
04260090040027EXCOR®P60P-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
04260090040225EXCOR®D03I-1112014-09-24
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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