Cardioplegia cannula

GUDID 10803622106504

LIVANOVA USA, INC.

Cardioplegia cannula
Primary Device ID10803622106504
NIH Device Record Key29f5340e-4e9a-4443-9e51-857cc847f526
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardioplegia cannula
Version Model NumberAR-xxxxx
Company DUNS080914995
Company NameLIVANOVA USA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100803622106507 [Primary]
GS110803622106504 [Package]
Contains: 00803622106507
Package: CASE [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-15
Device Publish Date2015-07-16

On-Brand Devices [Cardioplegia cannula]

10803622128353AR-xxxxx
10803622106511AR-xxxxx
10803622106504AR-xxxxx
10803622106252VC-xxxxx
10803622106245VC-xxxxx
10803622106238VC-xxxxx
10803622106221VC-xxxxx
10803622103114AR-xxxxx
10803622103091AR-xxxxx
10803622103084AR-xxxxx
10803622103077AR-xxxxx
10803622103060AR-xxxxx
10803622103053AR-xxxxx
10803622103046AR-xxxxx
10803622103039AR-xxxxx
10803622103022AR-xxxxx
10803622103015AR-xxxxx
10803622103008AR-xxxxx

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