FDA.reportPublic FDA data

AB5000

Primary DI
00813502010299
Brand
AB5000
Company
Abiomed, Inc.
Model
AB Pump Set 10mm/32 Apical (Hem)
Catalog number
055-1032-HV
Device description
Ventricular (Assist) Bypass
Published
2014-07-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
P900023052

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P900023052ABIOMED BVS(R) 5000 BI-VENTRICULAR SUPPORT SYSTEMAbiomed Cardiovascular, Inc.1992-11-20DSQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813502010299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813502010299008135020102998135020102990813502010299

GMDN Terms#

Term, Definition table
TermDefinition
Implantable ventricular circulatory assist systemA portable assembly of devices intended to provide mechanical assistance to a heart ventricle(s), typically by pumping blood from the left ventricle to the aorta through an extra-cardiac circuit. It includes an implantable pump(s), connecting cannula/graft(s), a percutaneous lead, and external components (e.g., battery pack, controller). It is typically intended to be used as a bridge to heart transplantation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
978.777.5410wbolt@abiomed.com

Regulatory Flags#

DUNS number
050636737
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813502013009Abiomed Low Profile Introducer Kit10004352026-01-12
00813502010411Impella RP Flex Introducer Kit20003422026-03-11
00813502011685Abiomed Impella CP 14Fr Introducer Kit0052-3052 2026-03-11
00813502011692Abiomed Impella CP 14Fr Introducer Kit 0052-3053 2026-03-11
00813502011678Abiomed Impella14Fr Introducer Kit, 13cm & 25cm0052-30462026-02-25
00813502013566Impella CP with SmartAssist100041310004132025-11-14
00813502010220Impella 14Fr Introducer Kit, long0052-00172025-10-16
00813502010015Impella0052-00110052-00112016-10-21
00813502011173Impella0046830046832014-09-03
00813502012729Impella10005340052-00382023-10-27
00813502012736Impella10005350052-00392023-10-27
00813502011388Impella0048-00320048-00032023-07-31
00813502011371Impella0048-00240048-00032019-04-18
00813502011876Impella0048-00450048-00032023-07-31
00813502013269Abiomed 14Fr Low Profile Introducer100045810004582024-05-13
00813502012279Impella10000800048-00032023-07-31
00813502013474Impella100055010005502023-10-27
00813502012910Impella100044110004412023-06-30
00813502012996Impella100043410004342023-05-31
00813502013252Impella100045710004572023-05-31

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