Cardioplegia solution administration adaptor

GUDID 10803622103794

LIVANOVA USA, INC.

Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor
Primary Device ID10803622103794
NIH Device Record Key8a9a31c3-2844-480a-b0f9-fe6759faf1dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameCardioplegia solution administration adaptor
Version Model NumberCA-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
GS100803622103797 [Primary]
GS110803622103794 [Package]
Contains: 00803622103797
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 solution administration adaptor]

10803622106634CA-xxxxx
10803622106627CA-xxxxx
10803622106610CA-xxxxx
10803622103794CA-xxxxx
10803622103787CA-xxxxx
10803622103770CA-xxxxx
10803622103763CA-xxxxx
10803622103756CA-xxxxx
10803622103749CA-xxxxx
10803622103732CA-xxxxx
10803622103725CA-xxxxx
10803622103718CA-xxxxx
10803622103701CA-xxxxx
10803622103695CA-xxxxx
10803622103688CA-xxxxx
10803622103671CA-xxxxx
10803622103664CA-xxxxx
10803622103657CA-xxxxx
10803622103640CA-xxxxx
10803622103633CA-xxxxx
10803622103626CA-xxxxx
10803622103619CA-xxxxx
10803622103602CA-xxxxx

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