Impella® 23F x 6cm Axillary Sheath 0052-3068

GUDID 00813502011784

Abiomed, Inc.

Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter Intracardiac circulatory assist axial-pump catheter
Primary Device ID00813502011784
NIH Device Record Key09e9b6f4-1694-458a-90da-343f5f3fa246
Commercial Distribution StatusIn Commercial Distribution
Brand NameImpella® 23F x 6cm Axillary Sheath
Version Model NumberKit, 23Fr Axillary Introducer, 6cm, ABMD
Catalog Number0052-3068
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100813502011784 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBIntroducer, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-28
Device Publish Date2020-07-20

Devices Manufactured by Abiomed, Inc.

00813502012729 - Impella2023-11-06 ABMD Intro Kit, 14Fr x Short, Pkgd US
00813502012736 - Impella2023-11-06 ABMD Intro Kit, 14Fr x Long, Pkgd US
00813502013474 - Impella2023-11-06 Kit, 14Fr Introducer, 13cm and 25cm
00813502011388 - Impella2023-08-08 Impella CP C7 w V3 GWRU Set, US
00813502011401 - Impella2023-08-08 Optical, AIC, Impella Connect, Pkgd, US
00813502011876 - Impella2023-08-08 Pump 371 14F LT CMR Set
00813502012279 - Impella2023-08-08 Pump 381 Pump Set (US)
00813502012910 - Impella2023-07-10 Introducer Kit 23Fr x 11cm

Trademark Results [Impella]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IMPELLA
IMPELLA
79134516 not registered Dead/Abandoned
Regal Beloit Australia Pty Ltd
2013-05-22
IMPELLA
IMPELLA
75534996 2443683 Live/Registered
ABIOMED, INC.
1998-08-07

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