FDA.reportPublic FDA data

EXCOR® VAD

Primary DI
04260090040409
Brand
EXCOR® VAD
Company
Berlin Heart GmbH
Model
C80G-040
Device description
Arterial cannula for infans
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H100004003

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260090040409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260090040409042600900404094260090040409

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
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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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

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