AB5000 0055-1242-SA

GUDID 00813502010398

Ventricular (Assist) Bypass

Abiomed, Inc.

Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system Implantable ventricular circulatory assist system
Primary Device ID00813502010398
NIH Device Record Key2fe91661-d736-4b0d-9a25-a915f130463a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAB5000
Version Model NumberAB Pump Set 12mm/42 Atrial (Sil)
Catalog Number0055-1242-SA
Company DUNS050636737
Company NameAbiomed, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com
Phone978.777.5410
Emailwbolt@abiomed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100813502010398 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSQVentricular (Assisst) Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-07-31

On-Brand Devices [AB5000]

00813502010848Ventricular (Assist) Bypass
00813502010831Ventricular (Assist) Bypass
00813502010817Ventricular (Assist) Bypass
00813502010800Ventricular (Assist) Bypass
00813502010794Ventricular (Assist) Bypass
00813502010787Ventricular (Assist) Bypass
00813502010770Ventricular (Assist) Bypass
00813502010763Ventricular (Assist) Bypass
00813502010756Ventricular (Assist) Bypass
00813502010749Ventricular (Assist) Bypass
00813502010732Ventricular (Assist) Bypass
00813502010725Ventricular (Assist) Bypass
00813502010718Ventricular (Assist) Bypass
00813502010701Ventricular (Assist) Bypass
00813502010695Ventricular (Assist) Bypass
00813502010688Ventricular (Assist) Bypass
00813502010671Ventricular (Assist) Bypass
00813502010404Ventricular (Assist) Bypass
00813502010398Ventricular (Assist) Bypass
00813502010381Ventricular (Assist) Bypass
00813502010374Ventricular (Assist) Bypass
00813502010367Ventricular (Assist) Bypass
00813502010350Ventricular (Assist) Bypass
00813502010343Ventricular (Assist) Bypass
00813502010336Ventricular (Assist) Bypass
00813502010329Ventricular (Assist) Bypass
00813502010312Ventricular (Assist) Bypass
00813502010305Ventricular (Assist) Bypass
00813502010299Ventricular (Assist) Bypass
00813502010282Ventricular (Assist) Bypass
00813502010275Ventricular (Assist) Bypass
00813502010268Ventricular (Assist) Bypass
00813502010251Ventricular (Assist) Bypass

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